Occlusal Splint and Counseling to Temporomandibular Disorder

Phase 3

• Conditions: Temporomandibular Disorders; Stress Psychological; Musculoskeletal Diseases
• Interventions: Procedure: stabilizing appliance; Procedure: Non-occluding splint, counseling

• Registration Number: NCT01544439
• Lead Sponsor: Patra-cia Rocha Coelho

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2012-02-23
• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-17
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

All subjects participated in this study volunteers by signing the consent form. Inclusion criteria are as follows:

• female subjects;
• aged 20 to 55 years;
• irrespective of race, social status or religion;
• presence of pain intensity of at least moderate (at least 4.0 on VAS), shown in the first clinical assessment;
• diagnosis of myofascial pain persisting for a minimum period of six months.

Exclusion Criteria

• history of psychiatric disorders or treatment for neurological or psychological disorders;
• volunteers with severe intellectual or physical disability that would hinder the collection of data;
• history of systemic diseases that generate joint symptoms, muscle or rheumatologic, such as rheumatoid arthritis and fibromyalgia;
• pain attributed to a well-defined local cause, such as pulpitis, trigeminal neuralgia and cancer pain;
• attributable to migraine pain or infection;
• report of any previous treatment for TMD;
• treatment with drugs affecting the central nervous system (muscle relaxants, anticonvulsants, opioids, and antidepressants) and treatment with analgesics and anti-inflammatory drugs, with or without prescription, concomitant therapies to be instituted in this research;
• report of facial trauma as a possible etiology of TMD;
• subject denture wearers an upper or lower;
• volunteers aged under 20 or over 55 years;
• male individuals.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral stabilization appliance,counselling	stabilizing appliance	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. Patients receive oral and written instructions about self-care (counseling), 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.
Non-occluding splint, counselling	Non-occluding splint, counseling	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, ie, 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. All patients will submitted 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.

Primary Outcome Measures

Name	Time	Method
Evaluation of physical symptoms	Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks.	The measurement of spontaneous orofacial pain intensity will be obtained through the Visual Analogue Scale (VAS). Evaluated before and after three months of interventions, will be obtained from the average intensity of pain experienced by each group. The evolution of physical symptoms reported in each group will verify the effectiveness of interventions instituted in each group.
Assessment of Quality of Life related to TMD	Participants will be monitored during the study period to assess changes in quality of life in 12 weeks	The comparison of scores in the two periods indicate a possible change in the index of quality of life. The instrument used for this will be the profile of the Oral Health Impact (OHIP-14).

Secondary Outcome Measures

Name	Time	Method
Evaluation of psycho-emotional aspects related to the TMD	The psycho-emotional aspects will be evaluated before and after the intervention period of three months (12 weeks) to initiation of therapy	The Diagnostic Criteria for Research of temporomandibular disorders (RDC / TMD, Axis II)will be used. To assess the impact of psycho TMD, we investigate measures of depression and nonspecific physical symptoms accompanied by pain (somatization).

Trial Locations

Locations (1)

Federal University of Juiz de Fora; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil