The transparency of reporting 'harms' encountered with the surgically assisted acceleration of orthodontic tooth movement in the published randomized controlled trials: a meta-epidemiological study
Progress in Orthodontics volume 24, Article number: 11 (2023)
Surgical-assisted accelerated orthodontics (SAAO) has become very popular recently. Therefore, this study aimed to investigate the extent to which researchers adhere to Item 19 (harms) of the Consolidated Standards of Reporting Trials (CONSORT) in the published studies in the field of SAAO. In addition, the study evaluated the possible association between harm reporting and the human development index (HDI) of the recruited research sample country, CiteScore-based quartile (CSBQ) of the publishing journal, invasiveness of the surgical intervention (ISI), and the type of orthodontic tooth movement (TOTM). Moreover, it aimed to summarize the different possible harms and complications that maybe encountered in the course of SAAO.
Materials and methods
Electronic searching of six databases was conducted for SAAO-related English RCTs published between January 2000 and April 2022. For the RCTs that did not report harms, information was sought by contacting the corresponding authors. Descriptive statistics of the evaluated variables were performed. The association between 'harm reporting' and the HDI of the research team, the BDRQ of the publication journal, the ISI, and the TOTM were investigated. Binary logistic regression was used, and the odds ratios (ORs) with 95% confidence interval (CIs) of the evaluated variables were obtained. Moreover, the risk of bias of the included RCTs was assessed using the RoB2 tool.
Among the 91 included RCTs, 54 RCTs (59.3%) did not adhere to reporting harm associated with the SAAO. The non-adherence was significantly associated with the ISI (OR 0.16; CI 0.03–0.73; p < 0.018) for invasive methods compared with minimally invasive ones). There was a significant positive correlation between harm reporting and both the CSBQ of the publishing journal and the HDI of the recruited research sample country (p = 0.001, p = 0.003, respectively). On the contrary, a non-significant association was found between harm reporting and the type of OTM (p = 0.695). The incidence of harms associated with SAAO was approximately 17.5%.
Assessment was restricted to English RCTs related to SAAO.
Conclusion and implications
The adherence to reporting harms in the field of SAAO was deficient. Efforts should be made by authors, peer reviewers, and editors to improve compliance with the CONSORT guidelines regarding harms reporting. Additionally, there is a wide spectrum of harms that could be associated with SAAO that the practitioner should pay attention to and alert the patient to the possibility of their occurrence.
Several methods for accelerating orthodontic tooth movement (OTM) have been proposed to reduce treatment time and achieve patient satisfaction . Acceleration methods can be divided into conservative approaches (biomechanical, biological, and physical) and surgical ones .
Currently, surgical interventions can be considered one of the most applied and tested acceleration methods that have shown promising results in shortening the duration of orthodontic treatment [2, 3]. Surgical acceleration methods all rely on one principle, the 'regional acceleratory phenomenon (RAP)', which was described by Frost as a complex reaction of tissues to a harmful stimulus . However, surgical interventions may be associated with many undesirable side effects such as tooth resorption as was reported by Tunçer et al. . They notified exposure of the central incisors to severe cervical resorption in a patient who underwent en masse retraction following premolars extraction assisted with piezoincisions . On the other hand, there have been other several reports regarding injuries associated with the surgical acceleration techniques like interdental bone loss [6, 7], tooth vitality loss [6, 8], scarring of the surgical site [9, 10], gingival recession [6, 11], mechanical root injury during surgery [12, 13], face and the neck subcutaneous hematomas , and bacteremia . From the ethical point of view, these harms should be mentioned in the final report of any clinical study (or trial) in order to alarm all practitioners about the possibility of having these hazards to their patients when undergoing surgically assisted acceleration of tooth movement . In addition, the omission of these harms may lead to misinterpretation and insufficient conclusions about the interventions evaluated . Moreover, that could influence medical decision making which is based on balancing benefits against risks .
To formulate high-quality protocols and to enhance the quality of reported RCTs, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) , as well as the CONSORT (Consolidated Standards of Reporting Trials) statement , were developed. Items 22 of the SPIRIT and 19 of the CONSORT are concerned with reporting the possible risks of the intended intervention in the information sheet or the actually encountered harms in the course of the accomplished trial, respectively . However, many RCTs give inadequate information on associated side effects. This lack of available information affects the transparency, and the reliability of the findings, as well as the decision to adopt the applied intervention . Nowadays, few meta-epidemiological studies (MES) have touched on that item within the field of medicine [16, 20, 21]. On the other hand, regarding orthodontics, only one MES investigated the quality of reporting of RCTs abstracts in the four major orthodontic journals between 2006 and 2011 . It found insufficient reporting of harms in the abstracts of the chosen RCT trials . Till now, there is no MES addressing the reporting of harms in the field of surgically assisted accelerated orthodontics (SAAO). Therefore, the overall goals of our current study were (1) to investigate the extent to which researchers adhere to Item 19 (harms) of the CONSORT 2010 statement in the SAAO treatments, (2) to evaluate of the possible association or correlation between the presence/absence of 'harms' reporting in the published paper with the country of recruited research sample, the scientific strength and prestige of the publishing journal, the invasiveness of the SAAO, the type of OTM, and (3) to display the different possible harms and complications that maybe encountered in the course of SAAO.
Materials and methods
This MES was constructed under 'Guidelines for reporting meta-epidemiological methodology research' .
Harms are defined as the totality of possible adverse consequences of an intervention or therapy. They are considered as the direct opposite of benefits, against which they must be compared . In this study, the harms related to the SAAO were classified into: (1) gingival soft tissue harms such as gingival recession, gingival tearing, surgical site scarring, excessive gingival bleeding, infection in the incision site, and gingival abscess, (2) alveolar bone harms such as alveolar bone loss, alveolar bone defects such as dehiscence and fenestration, and cortical bone fracture, (3) dental harms which include loss of tooth vitality, tooth sensitivity, root resorption, mechanical root injury, (4) harms related to patient-reported outcome measures (PROMs) such as pain, discomfort, swelling or edema, difficulty in eating, restriction of jaw movement, and fear of surgical intervention, and (5) other harms such as nerve injury (e.g., numbness), and hematoma.
Human development index (HDI)
Human Development Index (HDI) was adopted in the current study to classify the country of the recruited research sample of the included RCTs. HDI is a socio-demographic variable, which was introduced by the WHO in the 1990s . It helps classify the world's population into homogeneous groups based on more comprehensive indicators (being educated, living a long and healthy life, and enjoying a decent standard of living) and not on the purely economic value of each country . Countries divide into four wide groups of human development based on the numerical score obtained (ranging from 0 to 1) by the United Nations Development Programme (UNDP): 'group 1': very high HDI, 'group 2': high HDI, 'group 3': medium HDI, and 'group 4': low HDI .
CiteScore™-based quartile (CSBQ)
In the current study, to evaluate the impact of the publication journal of the included research paper, the CiteScore was used . The quartile-based classification was adopted. Mainly, CS-based quartiles in Scopus® were adopted to rank the journals of the included RCTs. Journals that were not indexed by Scopus®, were searched on the Web of Science™. The JIF/JCI-based quartiles in the Web of Science™ database were used on this occasion. If the journal was not found in these two major databases, it was considered 'Not indexed'.
Type of orthodontic tooth movement (OTM)
Orthodontic tooth movement that is assisted by one of the SAAO methods includes: retraction of (canine, en-mass, or incisors), decrowding of anterior teeth, impacted canine traction, and intrusion of molar or incisors.
Surgically assisted accelerated orthodontics (SAAO)
Surgical acceleration methods were divided into: (1) Invasive methods require full mucoperiosteal flaps, suturing with the potential associated surgical side effect . It included conventional corticotomy, distraction osteogenesis which is divided into periodontal ligament distraction or dentoalveolar distraction (DAD), periodontally accelerated osteogenic orthodontics (PAOO), or any surgical technique which is required raising flap. (2) Minimally invasive methods are characterized as flapless surgical techniques with negligible risk of associated side effects . It included corticision, piezocision, discision, micro-osteoperforations (MOPs), laser-assisted flapless corticotomy (LAAC), fibrotomy, interseptal bone reduction, or any surgical technique which is not required raising flap. However, some studies combine in their design two surgical acceleration methods (whether invasive vs. invasive, minimally invasive vs. minimally invasive, or invasive vs. minimally invasive), which was defined in this study as a "combination of invasive and minimally invasive procedures in a parallel group or split-mouth study designs".
Research articles were screened for eligibility using the following criteria:
All randomized controlled trials that were published between January 2000 to April 2022, as well as included healthy human participants of both gender who underwent fixed orthodontic treatment assisted with one of the surgical acceleration interventions (invasive or minimally invasive) compared with a non-accelerated group, or an accelerated group with another protocol or surgical technique, with no restriction for age, type of malocclusion and racial group. On the other hand, the non-RCTs, retrospective trials, animal trials, case reports or case series, and non-English language trials were excluded. The included RCTs in which the majority of their outcomes were directly related to the assessment of harms associated with the provided intervention (i.e., in which more than 50% of the harms classified under "SAAO-related harms" were evaluated as a secondary outcome), were deemed ineligible for inclusion in our study.
Electronic searching of the Cochrane Library, PubMed®, Scopus®, Web of Science™, and Google™ Scholar was conducted. Moreover, in addition to the search in Google™ Scholar to determine any relevant papers in the grey literature, a search in the OpenGrey was also performed. The systematic search was done by two authors (DTA and MYH). The search was restricted to articles published between January 2000 and April 2022. For additional sources and to ensure that no relevant research paper was left out, the reference list of the selected papers was also checked. More details about the search strategy used are given in Additional file 1: Table S1.
Study selection and data extraction
The potential eligible trials were screened separately by two authors (DTA and MYH). In case of any conflict, the third author (KD) was consulted to reach a resolution. The selection was carried out according to the following methodology: firstly, records from each database were imported into Endnote™ X9, and then merged into a single data unit to remove duplicate records and to facilitate retrieval of related articles. Then after deleting duplicate records, the titles and abstracts of the remaining articles in the Endnote™ list were only checked. Thereafter, the full text was evaluated if reading the title and abstracts did not help in deciding the eligibility of the article, as well as if the paper appeared to fit the inclusion criteria. Data were extracted by the same two investigators, then they were organized into a pre-designed table. From each study, the following data were obtained: the first author's name, year of publication, country where the study was carried out, Human Development Index (HDI) of the country of the recruited research sample (1 = very high human development, 2 = high human development, 3 = medium human development, 4 = low human development), journal of publication, and the CiteScore (CS) of the journal, the Quartile to which the journal belongs (Q) according to Scopus® indexing (Level 1 = Q1, Level 2 = Q2, Level 3 = Q3, Level 4 = Q4, Level 5 = Unclassified); a journal was labeled 'Not indexed' when it is was not found in both Scopus® and Web of Science™ databases. In addition, the following pieces of information were gathered: the type of OTM (1 = incisor, canine, or en-mass retraction, 2 = decrowding, 3 = all other OTM (e.g., molar or incisor intrusion), invasiveness of the SAAO (1 = invasive, 2 = minimally invasive, 3 = combination of invasive and minimally invasive procedures in parallel group or split-mouth study designs), adherence to harm reporting (1 = Yes, 2 = No), and the method of reporting harms (1 = reported under a definite subheading, 2 = reported inexplicitly within the Results or Discussion sections, 3 = not reported at all).
Information about the harms requested from the authors
For more information about the harms associated with SAAO, emails were sent to the corresponding authors of the included RCTs that did not report harm. After introducing ourselves and explaining the main purpose of this study, the authors were asked to help answer the following question: "Did any of your patients suffer harm from the surgical technique applied in accelerating orthodontic tooth movement?".
Risk of bias assessment
The risk of bias in the included RCTs was assessed by two reviewers (DTA and MYH) using the RoB-2 tool . In case of controversy, the third author (KD) was consulted to reach an agreement. Five domains were evaluated as 'low risk,' 'high risk' or 'some concern of bias' as follows: bias arising from the randomization process, bias due to deviations from intended interventions (which divided into effect of assignment to intervention, and effect of adhering to intervention), bias due to missing outcome data, bias in the measurement of the outcome, and bias in the selection of the reported result. Then, the overall risk of bias was judged as follows: “Low risk” if all fields were assessed as low risk of bias, “some concerns” if at least one field was judged as having some concerns without the presence of high risk of bias for any domain, and “high risk” if at least one or more domain were assessed as at high risk or in the case of having some concerns for multiple domains.
Descriptive statistics including the percentage and frequencies for each studied variable were calculated. Mann–Whitney test (U) was used to compare the harm reporting and the year of publication. The association between the categorical variables was detected. To investigate the association between harm reporting and CiteScore-based quartile of the publishing journal and HDI of the recruited research sample country, the rank biserial correlation was applied by using Spearman's Rho test (rs). Then, the strength of the relationship according to rs was defined as: 0.00–0.19 “very weak correlation”, 0.20–0.39 “weak correlation”, 0.40–0.59 “moderate correlation”, 0.60–0.79 “strong correlation”, and 0.80–1.0 “very strong correlation”. Chi-square and Fisher’s exact tests were applied to examine the association between harm reporting and both invasiveness of the SAAO, and the type of OTM. Then, the strength of the relationship was detected using Cramer's V (φc) as follows: from 0.00 to less than 0.10 “negligible association”, from 0.10 to less than 0.20 “weak association”, from 0.20 to less than 0.40 “moderate association”, from 0.40 to less than 0.60 “relatively strong association”, from 0.60 to less than 0.80 “strong association”, and from 0.80 to 1.00 “very strong association”. The threshold of statistical significance was determined at an alpha value of 0.05. In addition, to investigate the prediction model of reporting harms and estimate the odds ratios (ORs), binary logistic regression analysis was used. All statistical tests were carried out using the Statistical Package for the Social Sciences, version 23.0 (IBM SPSS Corp., Armonk, NY, USA).
Study selection and inclusion in the study
In this meta-epidemiological study, a flow diagram of study selection and inclusion is given in Fig. 1. After excluding ineligible articles, 101 papers identified from six databases were reviewed in depth. No papers that met the inclusion criteria were found in the grey literature. As a result, a total of 91 RCTs in the SAAO treatments were included in this study. More details about the excluded papers and the reasons beyond exclusion are illustrated in Additional file 2: Table S2.
Characteristics of included RCTs
The first SAAO-related RCT was published in 2007. Subsequently, the number of published SAAO-related studies increased dramatically from the year 2007 until 2022, where the peak of publishing was in 2019 and 2020 by 34 RCTs (37.4%) as presented in Fig. 2.
SAAO research teams of the included RCTs were distributed in seventeen countries worldwide. Moreover, nine of these countries are located in Asia. Two countries from Asia occupied the top ranks in the number of SAAO published papers, where 23 (25.3%) RCTs were conducted in India, and 15 (16.5%) SAAO trials were carried out in Syria. On the other hand, 18 (19.8%) trials were accomplished in Egypt, and 7 (7.7%) RCTs came from Turkey.
The number of SAAO papers conducted in the 'medium' human development countries was 56 trials (61.5%). In contrast, 23 RCTs (25.3%) and 12 RCTs (13.2%) were performed in both 'very high' and 'high' human development countries according to HDI data, respectively.
The American Journal of Orthodontics and Dentofacial Orthopedics, the Angle Orthodontist journal, and the European Journal of Orthodontics were the top three journals to publish SAAO-related papers, with 9, 8, and 5 published RCTs, respectively. Moreover, there were about 33 journals that published one article related to the topic of our current review.
However, 34.1% of the publishing journals belonged to the first quartile (Q1) in the hierarchy of journal's scientific impact according to Scopus®, whereas 22.0% of the included papers were published in non-indexed and unclassified journals in the main two bibliographic databases.
Orthodontic retraction of incisors, canines, or the upper six teeth together was the most applied orthodontic procedure in the included RCTs (68 trials: 74.7%). Regarding the invasiveness of the included interventions, the majority of the included trials involved minimally invasive surgical interventions (60 RCTs: 65.9%). Concerning the adherence to reporting of harms, 37 trials (40.7%) included information about the occurrence or absence of harms during the trial course. Six of them (6/37 RCTs: 16.21%) declared that harms had actually occurred with details about these events, whereas the rest (31/37 trials: 83.78%) reported the absence of any harms. On the other hand, 54 trials (59.3% of the whole included RCTs) did not report this element. Among the studies that reported harms, 18 trials (48.64%) allocated a specific paragraph under a definite subheading in the Results section, whereas in the rest of the papers (i.e., 19 trials: 51.35%), the information about possible harms or injuries were given inexplicitly in the context of the Results or Discussion sections of the manuscript. More details about the characteristics of included RCTs can be found in Table 1.
Risk of bias of the included studies
Of the 91 included RCTs, only 2 studies were judged as 'low risk of bias'. On the other hand, 55 RCTs were assessed as having 'some concern of bias', while the other 34 RCTs were at 'high risk of bias' (Table 2). However, the domain of deviations from intended interventions (effect of assignment to intervention or effect of adhering to intervention) was the most doubtful. The risk of bias of the included RCTs is presented in Additional file 3: Fig. S1. Moreover, the overall risk of bias for each domain is shown in Additional file 4: Fig. S2. More details about the bias risk assessment with supporting reasons for every judgment can be found in Additional file 5: Table S3.
The possible relationship between harm reporting (HR) and the other factors
No statistically significant difference between the RCTs who reported harm and those that did not report it, with regard to the year of article publication (U = 845, p = 0.210, Table 3). On the contrary, a positive correlation was found between HR and HDI, but this correlation was weak (rs = 0.30, p = 0.003, Table 3). In addition, examining the association between the HR and the CSBQ also showed a positive but weak significant correlation (rs = 0.34, n = 91, p = 0.001, Table 3).
An association between HR and the invasiveness of SAAO was tested. However, the result presented a moderate, positive significant association between the two variables (x2 = 7.543, φc = 0.28; p = 0.025, Table 3). The finding of the association between HR and the type of OTM showed a non-significant association between the two variables (p = 0.695). More information about the descriptive statistics of the proportions and the association between HR and other variables can be found in Table 3 and Figs. 3, 4, 5 and 6.
A binary logistic regression was carried out to assess the effect of HDI, the journal's quartile, and the invasiveness of the SAAO on the likelihood of reporting SAAO-related harms. The overall model was statistically significant when compared to the null model, (χ2(8) = 23.731, p = 0.003), which explained 31% of the variation of harms reporting (Nagelkerke R2) and correctly predicted 71.4% of cases. The Hosmer and Lemeshow goodness-of-fit test showed that this model had a good fit (p > 0.05). However, the odds of non-adherence with the harm reporting in invasive surgical methods was 0.16 times the odds of non-adherence in minimally invasive surgical methods (95% confidence interval [CI], 0.03–0.73; P < 0.05; Table 4).
Responses from authors regarding SAAO-related harms
Of the included RCTs, 54 studies did not adhere to reporting harm. When trying to communicate with authors via email, there were 8 corresponding authors whose email was not reported in the article. While the mentioned email address of one author was no longer available. In the end, 45 emails were sent to the corresponding authors asking them about the harms associated with SAAO in their RCTs. In the beginning, 17/45 authors responded to our mail. Later a reminder email was sent to authors who did not respond. As a result, we received a response from 6 other authors. However, 13 authors [28,29,30,31,32,33,34,35,36,37,38,39,40] reported that SAAO-related harms were observed in their trials. On the contrary, we received a report from 10 authors of the SAAO-related harms that occurred in their trials.
SAAO-related harms reported in the included trials
Of the 37 RCTs that reported a statement about any possible harms, 6 RCTs declared the presence of harms along with relevant details. From the 54 RCTs that did not address this issue, the corresponding authors of these papers were contacted and 10 trials were found associated with harms as shown in Tables 2 and 5 and Additional file 6: Table S4.
Gingival harms were documented in 7 (7.7%) papers. These included gingival recession , gingival bleeding [41,42,43], tearing of the gingival tissues , localized infection [45, 46], and gingival scarring following healing . Alveolar bone harms were found in two trials (2.2%; Table 5). These harms were either ectopic bony overgrowths  or bone sequestration . On the other hand, dental harms were found in two papers (2.2%; Table 5) and these were loss of tooth vitality  and tooth sensitivity . Harms that were related to patient-centered outcomes were mentioned in eight papers (8.8%, Table 5). These complications had several forms such as postoperative pain [41, 51, 52], discomfort [43, 50], swelling (which was reported by the patients themselves and not those observed by the researchers) [44, 50,51,52,53], and in one paper, dizziness and hypotension accompanied by fear of undergoing the surgical intervention . Also, there was a fear of repeating the surgical intervention . On the other hand, numbness  and hematoma [53, 55] were other harms associated with SAAO, with a proportion of 3.3% (i.e., 3/92 trials; Table 5). However, in all the harms that were reported, no validated tool was used to measure the occurred harm, only the type of it was mentioned.
In recent years, the trend toward the application of OTM acceleration methods, especially surgical ones, has increased. Undoubtedly, any intervention carries potential risks. Therefore, before making any treatment decision, it is necessary to weigh the potential benefits and risks in order to provide the best possible treatment for the patient . This leads to the question about the frequency and intensity of the possible associated harms with the SAAO and whether such harms have been adequately reported in the RCTs published in this regard.
The number of English RCTs carried out in the field of surgically accelerating OTM clearly increased, particularly in the last 5 years. The increasing desire of orthodontists to reduce the duration of orthodontic treatment to fulfill the requirements of adult patients , maybe one of the reasons behind the increasing research conducted in the field of SAAO.
Of the included RCTs, the percentage of non-adherence to reporting harms has reached 59.3%. This result is not surprising, as a low level of HR adherence is well recognized across other fields of dentistry [57, 58]. In addition, many studies in the medical field showed that adherence to CONSORT guidelines including the harms item was suboptimal and need to improve [59,60,61]. However, poor reporting of harm can be explained by some reasons. One of them may be the authors' lack of awareness of the details of harms-related data reporting accompanying the trials, which were clarified in the paper of the CONSORT extension to harms . On the contrary, some researchers prefer to focus on the positive aspects of the intervention, so they omit the occurred harms  which may be also one of the reasons for the underreporting of harm. Another reason could be publication bias, where researchers may believe that reporting harms associated with their research may negatively affect the ability to publish their trials, may revoke approval for funding for their research work [61, 62], or may affect negatively the widespread of their proposed surgical intervention . On the other hand, clinical trial participants need to be clearly and adequately informed of both the potential risks and benefits of the proposed intervention . Consequently, patients who have not received an adequate explanation of the nature of potential harms following surgical interventions may not be able to adequately report them.
According to our findings, there was no significant difference between the RCTs that reported harm and those that did not, with regard to the year of article publication. This result is in agreement with the findings of Khan et al. study , which found that HR in RCTs published in 3 high-impact cardiovascular journals, did not improve significantly over the study period (2011–2017).
Regarding the HDI, a positive correlation between the HR and the HDI was found. This means RCTs conducted in developed countries are more transparent in reporting SAAO-related harms. However, this contrasts with the results of Contopoulos-Ioannidis et al., who reported in their MES that poor reporting of harms is a global problem regardless of where the RCTs were conducted .
Concerning the CSBQ of the publishing journal, the correlation between HR and the CSBQ was positive. However, many high-quartile journals request authors to present the CONSORT checklist with manuscript submissions , which could be the reason behind the increased commitment of HR in the trials published in these journals. Although the correlation between the HR and both HDI and the CSBQ was statistically significant, it was a weak correlation. Therefore, this weak correlation is clinically insignificant for orthodontic practitioners.
Minimally invasive procedures (MIPs) dominated the acceleration techniques applied in the included studies. However, MIPs are flapless, therefore the pain and discomfort associated with these techniques are minimal, which positively affects the patient's acceptance . In addition, recovery is relatively faster, and the procedure time is less compared to other invasive procedures. This may be the reason for the popularity that MIPs have gained.
On the other hand, the odds ratio of not reporting harms in RCTs that applied invasive surgical acceleration methods was 0.16 times higher than in RCTs that applied minimally invasive methods. However, surgical acceleration methods, regardless of the technique applied, are fairly invasive, and therefore can be associated with complications . Furthermore, the more invasive, the more likely complications will occur. As mentioned earlier, authors may resort to hiding data related to Harms for fear that it will be difficult to publish their research . This may be the rationale behind the underreporting of harms in RCTs of invasive methods.
Regarding the type of OTM, no association between HR and the type of OTM applied in the included RCTs, was found. Of the included RCTs, orthodontic retraction (whether for canine, incisor, or en-mass) was the most frequently applied orthodontic procedure in the included studies. The reason for this may be that retraction cases require a total treatment period of about 2 years . Therefore, acceleration procedures of OTM may be useful in these cases.
Bias defines as "systematic error, or deviation from the truth, in results" . In our study, of the included RCTs, only two trials were assessed as low risk of bias, while the rest of the articles were either high risk or had some concern of bias. However, with the articles biased, the results of the trials will be affected and thus this affects the results reported in these articles, of which 'harms reporting'. This was noticed because some of the authors we contacted reported the occurrence of harms that were not mentioned in the text of the article.
Regarding the harms associated with SAAO, whether mentioned in studies or reported by authors via email, most were found to fall into the two categories of SAAO-related PROMs harms and SAAO-related gingival harms. However, concerning harms associated with invasive SAAO, DAD can be accompanied by loss of tooth vitality . While PAOO may be associated with occurring swelling and hematoma . On the other hand, conventional corticotomy may cause severe gingival inflammation and numbness. Whereas, full-thickness mucoperiosteal flap procedure may cause discomfort, edema, and tooth sensitivity . Regarding harms associated with minimally invasive SAAO, the application of piezocision can be accompanied by ectopic bony growth , bone sequestration , gingival recession , infection [2, 45], scarring , pain, and swelling. On the other hand, the application of MOPs may be associated with the following complications: bleeding [41, 43], redness , bruising , mucosal tear , pain [41, 51], discomfort , and swelling [44, 51].
The fact that SAAO-related harms occurred and did not mention in the published articles may indicate one of two things: either there is ignorance regarding the importance of item 19 of CONSORT, or this information has been deliberately hidden out of fear of refusal to accept the article’s publication.
In future trials, researchers must have an obligation to report harms that may be associated with their implementation of the surgical acceleration method. In addition, this notification must be sufficient by stating the nature of the damage, when it occurred, and how it was managed. Additionally, journal editors and reviewers should be more stringent about “harms reporting” as this has an impact on whether or not to adopt the proposed intervention.
Only English RCTs related to SAAO were included in this study. This study focused on the investigation of adherence to reporting harm associated with SAAO and did not address the other non-surgical acceleration methods. Moreover, other factors such as the number of medical centers involved in the RCT and the nature of funding for the RCT that may have a potential impact on the transparency of reporting harms, were not studied in this meta-epidemiological study.
The proportion of adherence to reporting harms in the field of SAAO was substandard (40.7%). Authors, peer reviewers, and editors must be stricter regarding compliance with the CONSORT guidelines regarding harms reporting. This will allow to weigh the benefits and harms of surgical acceleration techniques and thus optimally adopt the best procedure with the least complications or adverse effects. Patients should be fully aware of the complications that may accompany undergoing SAAO. Likewise, researchers must be fully aware of the harms associated with SAAO. On the other hand, it should be known that some factors may play a role in the adherence to reporting harm in the field of SAAO such as the scientific strength of the publishing journal assessed by the CiteScore-based quartile, the HDI of the recruited research sample country, and the invasiveness of the surgical intervention.
Availability of data and materials
The datasets and spreadsheets related to this manuscript can be obtained from the corresponding author upon reasonable request.
Surgically assisted accelerated orthodontics
Consolidated Standards of Reporting Trials
Human development index
Invasiveness of the surgical intervention
Type of orthodontic tooth movement
Orthodontic tooth movement
Standard Protocol Items: Recommendations for Interventional Trials
Randomized controlled trials
Patient-reported outcome measures
United Nations Development Programme
Journal impact factor
Journal citation indicator
Periodontally accelerated osteogenic orthodontics
Laser-assisted flapless corticotomy
- r s :
Spearman's Rho test
- φ c :
Nimeri G, Kau CH, Abou-Kheir NS, Corona R. Acceleration of tooth movement during orthodontic treatment-a frontier in orthodontics. Prog Orthod. 2013;14(1):1–8.
Al-Imam GMF, Ajaj MA, Hajeer MY, Al-Mdalal Y, Almashaal E. Evaluation of the effectiveness of piezocision-assisted flapless corticotomy in the retraction of four upper incisors: a randomized controlled clinical trial. Dent Med Probl. 2019;56(4):385–94.
Gibreal O, Hajeer MY, Brad B. Efficacy of piezocision-based flapless corticotomy in the orthodontic correction of severely crowded lower anterior teeth: a randomized controlled trial. Eur J Orthod. 2019;41(2):188–95.
Frost HM. The regional accelerated phenomenon. Orthop Clin North Am. 1981;12:725–6.
Tunçer N, Köseoğlu-Seçgin C, Arman-Özçırpıcı A. An unusual case of invasive cervical resorption after piezosurgery-assisted en masse retraction. Am J Orthod Dentofacial Orthop. 2019;156(1):137–47.
Amit G, Kalra J, Pankaj B, Suchinder S, Parul B. Periodontally accelerated osteogenic orthodontics (PAOO)-a review. J Clin Exp Dent. 2012;4(5): e292.
Lee W. Corticotomy for orthodontic tooth movement. J Korean Assoc Oral Maxillofac Surg. 2018;44(6):251–8.
Park YG. Corticision: a flapless procedure to accelerate tooth movement. Tooth Movement Front Oral Biol. 2016;18:109–17.
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, et al. Localized piezoelectric alveolar decortication for orthodontic treatment in adults: a randomized controlled trial. J Dent Res. 2016;95(9):1003–9.
Shenava S, Nayak K, Bhaskar V, Nayak A. Accelerated orthodontics-a review. Int J Sci Study. 2014;1(5):35–9.
Yavuz MC, Sunar O, Buyuk SK, Kantarcı A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018;19(1):1–7.
Dibart S, Yee C, Surmenian J, Sebaoun JD, Baloul S, Goguet-Surmenian E, et al. Tissue response during Piezocision-assisted tooth movement: a histological study in rats. Eur J Orthod. 2014;36(4):457–64.
Patterson BM, Dalci O, Papadopoulou AK, Madukuri S, Mahon J, Petocz P, et al. Effect of piezocision on root resorption associated with orthodontic force: a microcomputed tomography study. Am J Orthod Dentofacial Orthop. 2017;151(1):53–62.
Ileri Z, Akin M, Erdur EA, Dagi HT, Findik D. Bacteremia after piezocision. Am J Orthod Dentofacial Orthop. 2014;146(4):430–6.
Ioannidis JP, Evans SJ, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781–8.
Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169(19):1756–61.
Ioannidis JP, Lau J. Improving safety reporting from randomised trials. Drug Saf. 2002;25(2):77–84.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28–55.
Contopoulos-Ioannidis D, Tseretopoulou X, Ancker M, Walterspiel JN, Panagiotou OA, Maldonado Y, et al. Comparative rates of harms in randomized trials from more developed versus less developed countries may be different. J Clin Epidemiol. 2016;78:10–21.
Tedesco D, Farid-Kapadia M, Offringa M, Bhutta ZA, Maldonado Y, Ioannidis JPA, et al. Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited. J Clin Epidemiol. 2018;95:63–72.
Fleming PS, Buckley N, Seehra J, Polychronopoulou A, Pandis N. Reporting quality of abstracts of randomized controlled trials published in leading orthodontic journals from 2006 to 2011. Am J Orthod Dentofacial Orthop. 2012;142(4):451–8.
Murad MH, Wang Z. Guidelines for reporting meta-epidemiological methodology research. Evid Based Med. 2017;22(4):139–42.
García-TizónLarroca S, Amor Valera F, Ayuso Herrera E, Cueto Hernandez I, Cuñarro Lopez Y, De Leon-Luis J. Human Development Index of the maternal country of origin and its relationship with maternal near miss: a systematic review of the literature. BMC Pregnancy Childbirth. 2020;20(1):1–24.
Roldan-Valadez E, Salazar-Ruiz SY, Ibarra-Contreras R, Rios C. Current concepts on bibliometrics: a brief review about impact factor, Eigenfactor score, CiteScore, SCImago Journal Rank, Source-Normalised Impact per Paper, H-index, and alternative metrics. Ir J Med Sci. 2019;188(3):939–51.
Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016;17(1):1–12.
Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;28(366): l4898.
Agrawal AA, Kolte AP, Kolte RA, Vaswani V, Shenoy U, Rathi P. Comparative CBCT analysis of the changes in buccal bone morphology after corticotomy and micro-osteoperforations assisted orthodontic treatment: case series with a split mouth design. Saudi Dent J. 2019;31(1):58–65.
Al-Naoum F, Alsabbagh R, Aljundi A. Periodontally accelerated osteogenic non-extraction orthodontics versus conventional extraction-based orthodontics in dental decrowding: a randomized controlled trial. Int Arab J Dent. 2015;6(1):9–19.
Aristizabal JF, Bellaiza W, Ortiz MA, Franco L. Clinical and systemic effects of periodontally accelerated osteogenic orthodontics: a pilot study. Int j odontostomatol. 2016;10(1):119–27.
Bavikati VN, Muhameed AR, Mohaley N, Thimmaiah MK, Botlagunta KK, Basalingappa S. Effect of micro osteo-perforations (MOP) on the rate of tooth movement and levels of interleukin-1β-a split mouth study. Med Pharm Rep. 2022;95(1):65.
Kumar G, Rawat G, Amrita KV, Saimbi CS. Evaluation of enzyme activity and rate of tooth movement in corticotomy-accelerated tooth movement: a randomized clinical trial. J Orthod Sci. 2019;8:13.
Omidkhoda M, Radvar M, Azizi M, Dehghani M. Evaluating the efficacy of a modified piezo-puncture method on the rate of tooth movement in orthodontic patients: a clinical study. Turk J Orthod. 2020;33(1):13–20.
Raj SC, Praharaj K, Barik AK, Patnaik K, Mahapatra A, Mohanty D, et al. Retraction with and without piezocision-facilitated orthodontics: a randomized controlled trial. Int J Periodontics Restorative Dent. 2020;40(1):e19-26.
Shoreibah EA, Salama AE, Attia MS, Abu-Seida SM. Corticotomy-facilitated orthodontics in adults using a further modified technique. J Int Acad Periodontol. 2012;14(4):97–104.
Singh S, Jayan B. Comparative evaluation of periodontally accelerated osteogenic orthodontics (PAOO) versus conventional orthodontic tooth movement in adult patients with bimaxillary dentoalveolar protrusion. Int J Periodontics Restorative Dent. 2019;39(4):571–7.
Sivarajan S, Doss JG, Papageorgiou SN, Cobourne MT, Wey MC. Mini-implant supported canine retraction with micro-osteoperforation: a split-mouth randomized clinical trial. Angle Orthod. 2019;89(2):183–9.
Asif MK, Ibrahim N, Sivarajan S, HengKhiangTeh N, Wey MC. Osseous evidence behind micro-osteoperforation technique in accelerating orthodontic tooth movement: a 3-month study. Am J Orthod Dentofacial Orthop. 2020;158(4):579–86.
Sirri MR, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of corticision-based acceleration of lower anterior teeth alignment in terms of root resorption and dehiscence formation using cone-beam computed tomography in young adult patients: a randomized controlled trial. Int Orthod. 2021;19(4):580–90.
Bolat Gümüş E, Kınsız E. Effects of miniscrew-facilitated micro-osteoperforations on the rate of orthodontic tooth movement : A split-mouth, randomized controlled trial. J Orofac Orthop. 2022.
Fattori L, Sendyk M, de Paiva JB, Normando D, Neto JR. Micro-osteoperforation effectiveness on tooth movement rate and impact on oral health related quality of life. Angle Orthod. 2020;90(5):640–7.
Kundi IU, Shaheed S. Effect of miniscrews perforation on maxillary canine retraction rate. PJMD. 2018;38:309–13.
Teh NHK, Sivarajan S, Asif MK, Ibrahim N, Wey MC. Distribution of mandibular trabeculae bone volume fraction in relation to different MOP intervals for accelerating orthodontic tooth movement. Angle Orthod. 2020;90(6):774–82.
Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019;20(1):1–9.
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: a randomized clinical controlled trial. Dent Med Probl. 2020;57(3):285–93.
Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014;72(10):1880–9.
Tunçer NI, Arman-Özçirpici A, Oduncuoglu BF, Göçmen JS, Kantarci A. Efficiency of piezosurgery technique in miniscrew supported en-masse retraction: a single-centre, randomized controlled trial. Eur J Orthod. 2017;39(6):586–94.
Fernandes L, Figueiredo DSF, Oliveira DD, Houara RG, Rody WJ Jr, Gribel BF, et al. The effects of corticotomy and piezocision in orthodontic canine retraction: a randomized controlled clinical trial. Prog Orthod. 2021;22(1):1–11.
Al-Ainawi KI, Al-Mdalal Y, Hajeer MY. The effect of using a modified dentoalveolar distractor on canine angulation following rapid canine retraction: a split-mouth design randomized controlled trial. J Contemp Dent Pract. 2016;17(1):49–57.
Abdarazik MA, Ibrahim SA, Hartsfield JK, AlAhmady HH. The effect of using full thickness mucoperiosteal flap versus low level laser application on orthodontic tooth movement acceleration. Al-Azhar Dent J Girls. 2020;7(2):285–93.
Abdelhameed AN, Refai WMM. Evaluation of the effect of combined low energy laser application and micro-osteoperforations versus the effect of application of each technique separately on the rate of orthodontic tooth movement. Maced J Med Sci. 2018;6(11):2180–5.
El Mahlawy SA, Ibrahim SA, Salama AE, El-Kilani NS, Khalifa GA. Assessment of orthodontic treatment outcomes in maxillary protrusion enhanced by guided piezoelectric corticotomy with bone graft (comparative study). Al-Azhar Dent J Girls. 2020;7(4):621–5.
Thind SK, Chatterjee A, Arshad F, Sandhu PS, Thind MS, Nahin J. A clinical comparative evaluation of periodontally accelerated osteogenic orthodontics with piezo and surgical bur: an interdisciplinary approach. J Indian Soc Periodontol. 2018;22(4):328–33.
Sirri OR, Burhan AS, Hajeer MY, Nawaya FR, Abdulhadi A. Efficiency of corticision in accelerating leveling and alignment of crowded lower anterior teeth in young adult patients: a randomised controlled clinical trial. J Clin Diagn Res. 2020;14(10):1–6.
Simre SS, Rajanikanth K, Bhola N, Jadhav A, Patil C, Mishra A. Comparative assessment of corticotomy facilitated rapid canine retraction using piezo versus bur: a randomized clinical study. J Oral Biol Craniofac Res. 2022;12(1):182–6.
Keser E, Naini FB. Accelerated orthodontic tooth movement: surgical techniques and the regional acceleratory phenomenon. Maxillofac Plast Reconstr Surg. 2022;44(1):1–21.
Kshirsagar K, Bhate K, Shete A, Kakodkar P. Adherence to the Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Randomized Controlled Trials Related to Mandibular Third Molars. J Oral Maxillofac Surg. 2021;79(6):1207–13.
Shete-Motgi A, Shete M, Bhate K, Kshirsagar K, Kakodkar P. Analysis report of adherence to consort statement for reporting randomized controlled trials (RCTs) Associated with temporomandibular disorders (TMDs): a cross-sectional study. J Indian Acad Oral Med Radiol. 2022;34(1):22–6.
Devos F, Ibrahim N, Foissac F, Bouazza N, Ancel PY, Chappuy H, et al. Comparison of the quality of pediatric randomized controlled trials published in both nursing and medical journals: adherence to the CONSORT statement. Worldviews Evid Based Nurs. 2018;15(6):447–54.
Jauch K, Kowark A, Coburn M, Clusmann H, Höllig A. Randomized controlled trials on intracerebral hemorrhage: a cross sectional retrospective analysis of CONSORT item adherence. Front Neurol. 2019;10:991.
Ngah VD, Mazingisa AV, Zunza M, Wiysonge CS. A review of adherence and predictors of adherence to the CONSORT statement in the reporting of tuberculosis vaccine trials. Vaccines. 2020;8(4):770.
Smyth RM, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ. 2011;342: c7153.
Mitra-Majumdar M, Kesselheim AS. Reporting bias in clinical trials: progress toward transparency and next steps. PLoS Med. 2022;19(1): e1003894.
Bergus GR, Levin IP, Elstein AS. Presenting risks and benefits to patients. J Gen Intern Med. 2002;17(8):612–7.
Khan MS, Ochani RK, Shaikh A, Vaduganathan M, Khan SU, Fatima K, et al. Assessing the quality of reporting of harms in randomized controlled trials published in high impact cardiovascular journals. Eur Heart J Qual Care Clin Outcomes. 2020;6(2):177–9.
Lee SY, Teoh PJ, Camm CF, Agha RA. Compliance of randomized controlled trials in trauma surgery with the CONSORT statement. J Trauma Acute Care Surg. 2013;75(4):562–72.
Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022.
Alfailany DT, Hajeer MY, Burhan AS, Mahaini L, Darwich K, Aljabban O. Evaluation of the effectiveness of surgical interventions versus non-surgical ones when used in conjunction with fixed appliances to accelerate orthodontic tooth movement: a systematic review. Cureus. 2022;14(5): e25381.
Cumpston M, Li T, Page MJ, Chandler J, Welch VA, Higgins JP, Thomas J. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev. 2019;3(10):ED000142.
The authors would like to express their gratitude to all corresponding authors who responded to our email messages and collaborated with us.
This meta-epidemiological study was not funded.
Ethics approval and consent to participate
Consent for publication
The authors declare that they have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
. Electronic Search Strategy.
. Excluded studies after reading the full text and the reasons beyond exclusion.
. Risk of bias summary of the included RCTs. Low risk of bias (the + sign); some concern of bias (the - sign); high risk of bias (the X sign).
. Summary of the percentages of the risk of bias assessment for each domain.
. Details of the risk of bias assessment of the randomized controlled trials using the ROB-2 tool.
. Responses from authors regarding the SAAO-related harms.
About this article
Cite this article
Alfailany, D.T., Hajeer, M.Y. & Darwich, K. The transparency of reporting 'harms' encountered with the surgically assisted acceleration of orthodontic tooth movement in the published randomized controlled trials: a meta-epidemiological study. Prog Orthod. 24, 11 (2023). https://doi.org/10.1186/s40510-023-00457-4