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Selective outcome reporting in root coverage randomized clinical trials.

Daniel Isaac Sendyk1, Nathalia Vilela Souza1, João Batista César Neto1

  • 1Division of Periodontology, College of Dentistry, University of São Paulo, São Paulo, Brazil.

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|March 21, 2021
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Summary

Selective outcome reporting (SOR) is common in root coverage randomized clinical trials (RCTs), with nearly half of studies showing discrepancies between protocols and publications. This bias affects outcome presentation and trial interpretation.

Keywords:
gingival recessionpublication biasrandomized controlled trials as topicsurgery

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Area of Science:

  • Periodontology
  • Clinical Research Methodology

Background:

  • Outcome discrepancies between study protocols and publications introduce bias.
  • Selective outcome reporting (SOR) is a significant concern in scientific literature.

Purpose of the Study:

  • To assess the prevalence of selective outcome reporting (SOR) in root coverage randomized clinical trials (RCTs).

Main Methods:

  • A systematic review of published root coverage RCTs (July 2005 to March 2020) with publicly available protocols.
  • Comparison of discrepancies in primary and secondary outcomes between protocols and publications.
  • Evaluation of associations between trial characteristics and the occurrence of SOR.

Main Results:

  • Forty-four studies (54 publications) were analyzed, with a majority (77.3%) retrospectively registered.
  • Selective outcome reporting (SOR) was identified in 40.9% of trials, including outcome modification and omission.
  • SOR was significantly associated with study significance (p < 0.001) and unclear outcome definitions (p < 0.001).

Conclusions:

  • A high prevalence of selective outcome reporting (SOR) was found in root coverage RCTs.
  • The findings highlight the need for improved transparency and adherence to registered protocols in clinical trials.