Occlusal Splint and Counseling to Temporomandibular Disorder

Musculoskeletal Diseases Clinical Trial

Official title: The Efficacy of Occlusal Stabilization Appliance Associated to Counseling in the Management of Myofascial Pain Chronic and in the Improvement of the Quality of Life of Patients With Temporomandibular Disorders

Status Recruiting

Clinical Trial Summary

The aim of this study was to evaluate the effectiveness of the splint occlusal associated with counseling in reducing pain in patients with temporomandibular disorders, under the assumption that the occlusal appliance offers the highest rates of improvement than their placebo.

Clinical Trial Description

• The aim of this double-blind randomized control trial was to evaluate the efficacy of occlusal stabilization appliance associated to counseling in the management of myofascial pain chronic and in the improvement of the quality of life of patients with temporomandibular disorders (TMD).

• In order to reduce the likelihood of systematic errors and allow the use of statistical tests is used randomization processes or randomization of the volunteers in the different groups from a sequence generated by a specific program (Randomization.com), and the principal investigator masked for this division. For this, a second researcher, appointed to undertake the division of patients into groups that maintain confidential information from groups and their participants, revealing only the researcher therapist at the time of first therapy session. The number of individuals randomized to the experimental group will be equal to the control group.

1. Study Group Intervention The reversible occlusal therapy by stabilizing appliance used by patients in Study Group shall be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use.

2. Control Group Intervention The non-occlusive splint (placebo) will also be made by the same dental technician. They differ by the plates did not interfere with the occlusal tooth gear, i.e., do not alter the position of closing jaws. As not lead acrylic on the occlusal surfaces of teeth, adequate retention is given by an arch wire in orthodontic buccal surface of teeth. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the plate.

• In this study, all patients (study and control group) will undergo a counseling approach/self-care. Patients receive oral and written instructions about self-care, including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. The program also includes self-care guidelines on the use of moist heat or ice, use of soft diet, reduction of parafunctional habits (such as clenching and grinding your teeth or chewing gum), holding the rest of the postural position of the jaw (teeth apart , lips and tongue touching slightly pushing the front teeth), performing simultaneous bilateral chewing and modify posture to sleep. This approach will be reinforced verbally at each subsequent session. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Stress Psychological
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

• NCT number: NCT01544439
• Study type: Interventional
• Source: Federal University of Juiz de Fora
• Contact: Patricia R. Coelho, Master
• Phone: (32) 0032-1100
• Email: patriciacoelho.odonto@gmail.com
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2012
• Completion date: July 2012