Outcome reporting discrepancies between trial entries and published final reports of orthodontic randomized controlled trials

Koufatzidou, Marianna; Koletsi, Despina; Fleming, Padhraig S.; Polychronopoulou, Argy; Pandis, Nikolaos

doi:10.1093/ejo/cjy046

Cited by 38 publications

(36 citation statements)

References 20 publications

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“…These rates are comparable to those observed in studies in the medical field: 62% in the milestone paper from Chan et al. (), 49% in haematology journals (Wayant et al., ), 49% in trials of surgical interventions (Hannink, Gooszen, & Rovers, ) and 47% in orthodontic trials (Koufatzidou et al., ). However, there is high heterogeneity in the scientific literature, when it comes to the prevalence of outcome discrepancies.…”

Section: Discussionsupporting

confidence: 75%

“…In these cases, it was not possible to verify if the discrepancy favoured statistically significant results. Other studies (Fleming et al., ; Koufatzidou et al., ) also could not observe an association between outcome discrepancies and the presence of positive outcomes reported.…”

Section: Discussionmentioning

confidence: 85%

“…This is one of the reasons why registration of clinical trials and pre‐specification of all outcomes reported and their time frames is mandatory. However, investigations still show a high prevalence of selective outcome reporting in the medical literature (Aggarwal & Oremus, ; Chan et al., ; Fleming et al., ; Jones et al., ; Koufatzidou et al., ; Mathieu et al., ; Weston et al., ; Zhang et al., ). Likewise, our study confirmed the existence of discrepancies between registered trial protocols and publications in the field of dental implants.…”

Section: Discussionmentioning

confidence: 99%

“…Discrepancies between outcomes in protocols and publication have been observed in oral health Cochrane systematic reviews (Pandis, Fleming, Worthington, Dwan, & Salanti, ). A recent study (Koufatzidou, Koletsi, Fleming, Polychronopoulou, & Pandis, ) reported SOR in 47 percentage of publications in orthodontic randomized controlled trials. However, information about SOR is still scarce in most of the dental specialties.…”

Section: Introductionmentioning

confidence: 99%

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Selective outcome reporting in randomized clinical trials of dental implants

Sendyk

Rovai

Souza

et al. 2019

J Clinic Periodontology

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Aim: Selective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a trial protocol is changed or omitted in the paper. The purpose of this study was to evaluate the prevalence of SOR in publications of randomized clinical trials (RCT) concerning dental implants. Materials and Methods:Two reviewers independently screened protocols registered at ClinicalTrials.gov until February/2019. If the protocol met the eligibility criteria, the reviewers tried to identify the corresponding publication. Data extraction was carried out by the same reviewers. Primary and secondary outcomes were recorded for each trial and compared to outcomes previously described in protocols. Results:A total of 49 protocols were included. SOR was identified in 27 (55.1%) trials.The major discrepancies were as follows: protocol-defined primary outcome omitted in the publication (n = 6, 12.2%), new primary outcome introduced (n = 8, 16.3%), discrepancy in the primary outcome time frame (n = 17, 34.7%) and new secondary outcome introduced (n = 31, 63.3%). SOR was significantly associated with industry funding (p = 0.04) and timing of registration (p = 0.04). Conclusions:Our results indicate a high rate of SOR in dental implants clinical trials.Use of registry data during the peer-review process may help decreasing SOR. K E Y W O R D S dental implant, randomized clinical trials, selective reporting | 759 SENDYK Et al. S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section at the end of the article. How to cite this article: Sendyk DI, Rovai ES, Souza NV, Deboni MCZ, Pannuti CM. Selective outcome reporting in randomized clinical trials of dental implants. J Clin Periodontol. 2019;46:758-765. https ://doi.

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Section: Discussionsupporting

confidence: 75%

Section: Discussionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Selective outcome reporting in randomized clinical trials of dental implants

Sendyk

Rovai

Souza

et al. 2019

J Clinic Periodontology

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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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