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Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

Publication ,  Journal Article
Allareddy, V; Rampa, S; Masoud, MI; Lee, MK; Nalliah, R; Allareddy, V
Published in: Am J Orthod Dentofacial Orthop
November 2014

INTRODUCTION: The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. METHODS: The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. RESULTS: A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. CONCLUSIONS: Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics.

Duke Scholars

Published In

Am J Orthod Dentofacial Orthop

DOI

EISSN

1097-6752

Publication Date

November 2014

Volume

146

Issue

5

Start / End Page

587 / 593

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Single-Blind Method
  • Sex Factors
  • Sample Size
  • Research Support as Topic
  • Research Design
  • Registries
  • Randomized Controlled Trials as Topic
  • Orthodontics
 

Citation

APA
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ICMJE
MLA
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Allareddy, V., Rampa, S., Masoud, M. I., Lee, M. K., & Nalliah, R. (2014). Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry. Am J Orthod Dentofacial Orthop, 146(5), 587–593. https://doi.org/10.1016/j.ajodo.2014.07.019
Allareddy, Veerasathpurush, Sankeerth Rampa, Mohamed I. Masoud, Min Kyeong Lee, Romesh Nalliah, and Veerajalandhar Allareddy. “Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.Am J Orthod Dentofacial Orthop 146, no. 5 (November 2014): 587–93. https://doi.org/10.1016/j.ajodo.2014.07.019.
Allareddy V, Rampa S, Masoud MI, Lee MK, Nalliah R. Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):587–93.
Allareddy, Veerasathpurush, et al. “Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.Am J Orthod Dentofacial Orthop, vol. 146, no. 5, Nov. 2014, pp. 587–93. Pubmed, doi:10.1016/j.ajodo.2014.07.019.
Allareddy V, Rampa S, Masoud MI, Lee MK, Nalliah R. Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):587–593.
Journal cover image

Published In

Am J Orthod Dentofacial Orthop

DOI

EISSN

1097-6752

Publication Date

November 2014

Volume

146

Issue

5

Start / End Page

587 / 593

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Single-Blind Method
  • Sex Factors
  • Sample Size
  • Research Support as Topic
  • Research Design
  • Registries
  • Randomized Controlled Trials as Topic
  • Orthodontics