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

Effectiveness of a Counseling Program for TMD Treatment

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).

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorders
• Intervention / Treatment: Behavioral: Counseling; Device: Interocclusal Appliances

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Counseling Group; Patients allocated to the counseling group (Group I) were informed about possible etiological factors and educated to 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, as a way of reinforcing the information provided during the initial consultation. In subsequent returns at 7, 15, 30 and 60 days of follow-up, the instructions were given again and patients were asked whether they had detected any habits related to the initiation and maintenance of painful symptoms of TMD, as a way to further highlight the association between the presence of these harmful behaviors and the worsening signs and symptoms of TMD.	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.
Active Comparator: Splint Group; Patients allocated to the splint group (Group II) were treated using interocclusal appliances, according to the following protocol: At baseline, an anterior bite plate (front-plateau) was made from acrylic resin that was placed in the maxillary arch to include the the canine to canine region and promote the disocclusion of the posterior teeth. Patients were instructed to use the device for 24 hours, interspersed with rests of equal length during the first week. After 7 days, the device was removed. A hard splint was then made. At 30 days of follow-up, the splint was fitted and the patients were also asked to use it when they were sleeping.	Device: Interocclusal Appliances; Patients were treated using interocclusal appliances

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as measured by Visual Analogue Scale (VAS)	Visual Analogue Scale	Baseline, 7, 15, 30, 60 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 200/11-P CEP/UFRN