Effectiveness of a Counseling Program for Temporomandibular Disorders (TMD) Treatment

Not Applicable

Completed

• Conditions: Temporomandibular Disorders

• Registration Number: NCT02380105
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

This study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD).

Detailed Description

In this study, 51 patients were allocated to one of the research groups. In Group I, it was instituted counseling therapy. For Group II was conducted treatment as usual with occlusal splint. Patients were followed for returns at 7, 15, 30 and 60 days after baseline. At baseline, all patients were examined and assessed Research Diagnostic Criteria/Temporomandibular Disorder (RDC/TMD form). In addition, the patients were referred for specific treatment according to the group to which belonged. In each session, patients were also surveyed about pain intensity using a Numeric Scale. To analyze the impact of pain on quality of life, Oral Health Impact Profile (OHIP-14) questionnaire was used.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Study First Submitted: 2014-11-14
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Female individuals
• Positive diagnosis of TMD according to RDC/TMD
• Presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the Numeric Scale of pain

Exclusion Criteria

• TMD treatment for ongoing pain
• Presence of pulpal or periodontal disease
• Orthodontic treatment in progress
• Daily use of analgesics, antidepressants or muscle relaxants
• History of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain as measured by Visual Analogue Scale (VAS)	Baseline, 7, 15, 30, 60 days	Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Quality of life measured by Oral Health Impact Profile (OHIP)	Baseline, 7, 15, 30, 60 days	Oral Health Impact Profile
Functional Evaluation measured by TemporoMandibular Index (TMI)	Baseline, 7, 15, 30, 60 days	Temporomandibular Index