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Clinical Trials in TMD Sections
Author Bio
Introduction
The Biopsychosocial Model
Designing Multicenter RCTs
Players in an RCT
Randomization
Trial Design Quality
TMD Case Definition
Endpoints and Outcome Measures
Blinding & Masking
Study Sample Size
Currently selected section: Number and Nature of Interventions
Study Length and Follow up
Intent-to-treat Analyses and Sample Size
Compliance
Multicenter RCTs
Implementing RCTs: Practical Issues
Analysis of TMD Trials
Conclusions
Acknowledgments
Appendix A
Appendix B

 

Chapter 22: Clinical Trials in Temporomandibular: Number and Nature of Interventions
        

Number of Intervention Groups

Over half of the published RCTs on occlusal splints have included three or more groups. Although more than two groups can be valuable, seasoned investigators advise that RCT planners should proceed cautiously into this realm (Green, 2002).

Oftentimes including an additional group is overly ambitious and mainly serves to dilute the already scarce resources for the main two groups. It is critical to determine if the additional group will add to overall aim and scientific question at hand. Most prior TMD trials have been underpowered, and adding a third group was undoubtedly a contributing factor to this for many of them.

If resources are not unduly limited, multi-arm trials or factorial designs can efficiently answer more than one scientific question. An example of a factorial design would include four groups:

  • A control group of usual TMD treatment
  • A group of usual treatment plus group counseling sessions
  • A group of usual treatment plus a muscle relaxant medication
  • A group of usual treatment plus muscle relaxant and group counseling



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