CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Biofeedback-Based Cognitive Behavioral Treatment +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00769561
NCT00769561Phase 3Completed

Comparison of a Biofeedback-Based Cognitive Behavioral Treatment and Occlusal Splint Therapy for Temporomandibular Disorders. A Randomized Clinical Trial.

Philipps University Marburg·interventional·Posted Oct 9, 2008·Updated Dec 30, 2013

In Brief

A Phase 3 clinical trial evaluating Biofeedback-Based Cognitive Behavioral Treatment and Dental treatment with occlusal splint (OS) for Temporomandibular Disorders. Completed, enrolled 58 participants across 2 sites.

Detailed Summary

The purpose of this study is to develop and evaluate a biofeedback-based cognitive behavioral treatment for patients with chronic temporomandibular disorders using a randomized controlled design.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 9, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.7 years ago

Interventions

Biofeedback-Based Cognitive Behavioral Treatmentbehavioral

The biofeedback-based cognitive behavioral intervention comprises 8 individual sessions, each containing both cognitive behavioral and biofeedback elements. Treatment elements are education about the disorder, biofeedback training aimed at improving proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore patients receive portable biofeedback devices for EMG-biofeedback training during day and nighttime in order to reverse diurnal and nocturnal bruxing habits.

Dental treatment with occlusal splint (OS)device

Maxillary or mandibular occlusal splints are made of hard acrylic after taking impressions of the upper and lower dental arches, face bow registration and recording of centric relation. Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night and during day time for a period of 7 weeks. One week after initial insertion of the splint patients are requested to return for adjustment.