Risk of bias and magnitude of effect in orthodontic randomized controlled trials: a meta-epidemiological review

Koletsi, Despina; Spineli, Loukia M.; Lempesi, Evangelia; Pandis, Nikolaos

doi:10.1093/ejo/cjv049

Cited by 28 publications

(23 citation statements)

References 32 publications

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“…A modification of this tool was utilized for the included in-vitro/pre-clinical studies, as no pre-determined guidelines to assess the risk of bias exist and in order to incorporate specific important elements that would help identify the presence of potential bias. These include selection bias [17,18], performance bias [19], attrition bias [20] and reporting issues [21,22].…”

Section: Risk Of Bias Assessment Within Individual Studiesmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

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Use of thermoplastic material in orthodontics, either as aligner or as retainer appliances, is common practice and is likely to increase in the years to come. However, no systematic assessment on safety considerations of these adjuncts has been implemented up to date. The aim of this systematic review was to collectively appraise the existing evidence from both clinical and laboratory studies, on whether these appliances are associated with any estrogenic/cytotoxic effects or bisphenol-A (BPA) and monomer leaching. Eight electronic databases were searched with no limits in December 22, 2019, for published and unpublished research. Eligibility criteria comprised of studies of any design, describing use of any type of thermoplastic aligner. Study selection, data extraction and risk of bias (RoB) assessment was done independently, either in duplicate or confirmed by a second reviewer. Random effects meta-analyses of weighted mean differences (WMD) with associated 95% Confidence Intervals (CIs) were planned. Quality of the evidence was evaluated with Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of 58 articles were initially identified, while 5 were included in qualitative synthesis and 2 of those contributed to the quantitative syntheses. Four studies were in-vitro, while one was a randomized controlled trial; all assessed some type of orthodontic aligner or retainer, either as-received or retrieved. Risk of bias recordings ranged between unclear and high for all studies. Proliferation induction capacity of thermoplastic appliances’ eluents on MCF-7 cells failed to be confirmed compared to beta-estradiol (2 studies: 5% v/v, WMD: −182.08; 95% CI: −198.83, −165.33; p-value < 0.001; and 20% v/v, WMD: −184.53; 95% CI: −206.17, −162.88; p-value < 0.001). No cytotoxic activity was detected as well. In addition, although evidence from in-vitro studies was indicative of no traceable detection of BPA or other monomers, the findings from a single clinical trial were allied to increased levels of BPA in whole stimulated saliva, after up to 30 days of thermoplastic retainer usage, compared to standard Hawley retainer. The quality of the evidence overall was low to medium. Current data from in-vitro research are indicative of an absence of an estrogenic or cytotoxic effect of thermoplastic aligners or retainers. Regarding BPA or monomer release, evidence from clinical and laboratory studies appear inconsistent.

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Section: Risk Of Bias Assessment Within Individual Studiesmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

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“…Second, many important details of the study design, such as the selection of patient-centered research questions and outcome measures, are not considered by LOE. [52][53][54] Hence, if time allows, we still advise readers to focus on not only study design but also specific methodological details, [55][56][57] and to use multiple assessment tools when evaluating the quality of research articles.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

The Characteristics and Level of Evidence of Clinical Studies Published in 5 Leading Orthodontic Journals

Chen

Hua

Yan

et al. 2019

Journal of Evidence Based Dental Practice

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Objectives: To assess the characteristics and level of evidence (LOE) of clinical studies recently published in leading orthodontic journals, and explore the association between LOE and potentially related factors. Methods: The official online archives of five leading orthodontic journals were handsearched to identify clinical research articles published during 2015 to 2017. The LOE of all included studies was assessed using a modified LOE classification system developed based on the Oxford LOE and GRADE (Grading of Recommendations Assessment, Development and Evaluation). Univariable and multivariable logistic regression analyses were performed to identify the association between the LOE of each article (high LOE vs. low LOE) and 7 factors. Results: A total of 637 studies were included and assessed. Of these, 8 (1.3%) were level-1 studies, 160 (25.1%) were level-2, 326 (51.2%) were level-3, and 143 (22.4%) were level-4. According to multivariable logistic regression analyses, journal of publication (P<0.001), funding status (P=0.003), and the geographic origin of the first author (P=0.006) were significantly associated with LOE. Conclusions: The number of high LOE studies in leading orthodontic journals was limited. There is still need for further improvement in the overall LOE of clinical studies in orthodontics.

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“…To analyze the impacts of RoB on treatment effects for each domain, we used an approach previously described [15]. Binary and continuous studies were analyzed separately to reduce the heterogeneity introduced by the different types of outcomes [18].…”

Section: Discussionmentioning

confidence: 99%

“…As for a multi-arm RCT, the control group was split into more groups with smaller sample size, which were then compared with other experimental groups respectively to avoid the error of in ating sample size during statistical analysis [15]. For instance, a three-arm RCT was converted into two pair-wise comparisons by dividing the control group into two control groups with smaller sample size.…”

Section: Discussionmentioning

confidence: 99%

“…Some studies found that RoB in RCTs could lead to overestimation or underestimation of treatment effects [4,12,13], while others reported negative results [14]. A study focusing on RCTs in orthodontics suggested that RCTs with high RoB in the domains of random sequence generation and incomplete outcome data had found exaggerated treatment effects [15].…”

Section: Introductionmentioning

confidence: 99%

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Impact of risk of bias on the magnitude of treatment effects of randomized controlled trials in implant dentistry

Ding

et al. 2020

Preprint

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Background: Risk of bias (RoB) could influence the magnitude of treatment effects of randomized controlled trials (RCTs). This study aims to investigate the potential influence of RoB on treatment effects estimates in RCTs in implant dentistry. Methods: The RCTs published in five leading oral implant journals during the recent five years were electronically searched. The RoB was assessed using the Cochrane Collaboration RoB tool. The meta-regression analysis and Monte Carlo permutation test were performed to identify the association between RoB and the magnitude of treatment effects.Results: A considerable amount of studies have high RoB in blinding of participants and personnel, and unclear RoB in allocation concealment and selective reporting. The treatment effects were exaggerated by flaws in allocation concealment for binary outcomes and by deficiencies in random sequence generation and selective reporting for continuous outcomes.Conclusion: RoB frequently exists in RCTs recently published in implant dentistry, which may lead to the exaggeration of treatment effects. Better study design, implementation, and reporting are required for clinical trials in implant dentistry to ensure more reliable evidence.

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Risk of bias and magnitude of effect in orthodontic randomized controlled trials: a meta-epidemiological review

Cited by 28 publications

References 32 publications

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

The Characteristics and Level of Evidence of Clinical Studies Published in 5 Leading Orthodontic Journals

Impact of risk of bias on the magnitude of treatment effects of randomized controlled trials in implant dentistry

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