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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
Currently selected section: 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: Blinding and Masking
          

Question 9.1

A randomized trial to evaluate different types of occlusal splints was proposed, and, initially, the investigators did not design any blinding of either the subjects or the observers. A conference of TMD clinicians and clinical trial specialists got together and proposed some blinding options for this study.

Which of the following blinding methods do you think they chose for this study?

Selection AThe patient is given either a maxillary occlusal splint that covers the teeth, or one that covers the palate without the teeth. The observer and clinician are aware of the type of splint each subject has, and of the study hypotheses. The clinician tells the patient that they believe the occlusal splint will decrease the pain more than the palatal types.
Selection BThe patient is given one of these splints, and the observer and clinician are aware of the patient's treatment group. The patient is told that neither splint is known to be superior to the other.
Selection CThe patient is not told which splint type may be favored, and the observer/examiner is also not aware of the splint type that the patient is given. The clinician, however, is aware of the treatment assignment.
Selection DThe patient is not told which splint type may be favored, and the observer is also not aware. The main treating clinician is also not aware of the type of splint used with each patient, and only a second clinician, who is only in charge of the splint adjustment, is privy to this information.
Selection EAll the conditions are the same as #4, although now the statistician who is analyzing the data is not aware of the treatment assignment of the study subjects for the initial analyses.

 



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