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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
Number and Nature of Interventions
Currently selected section: 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: Study Length and Follow up
        

Length of Study

Since TMD is a chronic pain condition, designing an RCT to assess the outcome of the interventions for 3 months or less is not meaningful. Longitudinal studies show TMD is commonly a fluctuating condition, characterized by intermittent periods of relief and temporary success from a wide variety of treatments (Ohrbach and Dworkin, 1998). With this clinical course and natural history in mind, it becomes clear that it is essential that changes in clinical status be evaluated not only right after treatment has been completed but also for some time longer.

A minimal follow up period of one year is recommended for RCTs evaluating TMD clinical interventions. However, less than 25% of the 22 published RCTs on occlusal splints reported their findings beyond three months. Practical obstacles to longer trials include dealing with the problem of loss to follow up; yet planning on how to cope with these hurdles is advised, rather than conducting a short trial with low loss to follow up that may not offer much useful information for this long-standing condition.


 


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