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

Temporomandibular Disorders Clinical Trial

Official title:

Effectiveness of a Counseling Program for TMD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380105
• Other study ID #: 200/11-P CEP/UFRN
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: February 27, 2015
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2015
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral:
• Counseling
Patients were informed of their condition and possible etiological factors contributing to the pathology. They were also educated about the postural rest position of the mandible and instructed to perform bilateral chewing and not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions for future reference, as a way of reinforcing the information provided during the initial consultation.

Device:
• Interocclusal Appliances
Patients were treated using interocclusal appliances

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by Visual Analogue Scale (VAS)	Visual Analogue Scale	Baseline, 7, 15, 30, 60 days	No
Secondary	Quality of life measured by Oral Health Impact Profile (OHIP)	Oral Health Impact Profile	Baseline, 7, 15, 30, 60 days	No
Secondary	Functional Evaluation measured by TemporoMandibular Index (TMI)	Temporomandibular Index	Baseline, 7, 15, 30, 60 days	No