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

NCT02380105 | Completed

• 1 other identifier: 200/11-P CEP/UFRN
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Temporomandibular Disorders

Outcome Measures

Primary Outcomes (1)

• Pain as measured by Visual Analogue Scale (VAS)

  Visual Analogue Scale

  Baseline, 7, 15, 30, 60 days

Secondary Outcomes (2)

• Quality of life measured by Oral Health Impact Profile (OHIP)

  Baseline, 7, 15, 30, 60 days

• Functional Evaluation measured by TemporoMandibular Index (TMI)

  Baseline, 7, 15, 30, 60 days

Study Arms (2)

Counseling Group

EXPERIMENTAL

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

Splint Group

ACTIVE COMPARATOR

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

Interventions

Counseling BEHAVIORAL

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.

Counseling Group

Interocclusal Appliances DEVICE

Patients were treated using interocclusal appliances

Splint Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Counseling

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: de Freitas

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: March 5, 2015
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: March 5, 2015

Record last verified: 2015-02