Skip to Content
Interactive Textbook on Clinical Symptom Research Logo


Home Button

Clinical Trials in TMD Sections
Author Bio
Introduction
The Biopsychosocial Model
Currently selected section: Designing Multicenter RCTs
Players in an RCT
Randomization
Trial Design Quality
TMD Case Definition
Endpoints and Outcome Measures
Blinding & Masking
Study Sample Size
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: Designing Multicenter RCTs
        

What RCT Does Best

Clinical trials are best suited to evaluate treatment interventions. The primary advantages of the clinical trial design are:

  • It is prospective, or longitudinal, following people over time
  • The investigator allocates, at random, the type(s) of treatment(s) to the pool of clinical subjects (Hennekens and Buring, 1987)

The RCT approach creates two or more groups to be assessed with equivalent follow up measures and who, on average, are similar on known and unknown variables that can influence the outcome of treatment. For example, there is evidence that resolving a current TMD condition depends upon whether the person has ongoing psychosocial distress, such as depression, somatization, or anxiety disorders (Ohrbach and Dworkin, 1998). If, in a clinical trial for TMD, one treatment group has more distressed people then the other, than any differences in their treatment outcomes may merely reflect the maldistribution of this prognostic factor.

Some might assume that all aspects of TMD are best studied using RCTs. However, it is important to recognize that many important aspects of TMD are difficult or impossible to investigate via RCTs including frequency, etiology, diagnosis, prognosis, pathophysiology, etc.

 


Page 13 of 81
      Previous Section