Occlusal Splint and Counseling to Temporomandibular Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Federal University of Juiz de Fora.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Federal University of Juiz de Fora
Information provided by (Responsible Party):
Patra-cia Rocha Coelho, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier:
NCT01544439
First received: February 23, 2012
Last updated: May 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Temporomandibular Disorders
Stress Psychological
Musculoskeletal Diseases
Procedure: stabilizing appliance
Procedure: Non-occluding splint, counseling
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Federal University of Juiz de Fora:

Primary Outcome Measures:
  • Evaluation of physical symptoms [ Time Frame: Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be monitored during the study period to assess changes in quality of life in 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Evaluation of psycho-emotional aspects related to the TMD [ Time Frame: The psycho-emotional aspects will be evaluated before and after the intervention period of three months (12 weeks) to initiation of therapy ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral stabilization appliance,counselling
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.
Procedure: stabilizing appliance
The reversible occlusal therapy 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.
Other Names:
  • Occlusal stabilization appliance
  • Oral splints
  • Stabilization splint theraphy
Placebo Comparator: Non-occluding splint, counselling
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.
Procedure: Non-occluding splint, counseling
The non-occlusive splint (placebo) will also be made by the same dental technician. They did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. 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 splint.
Other Names:
  • Splint control
  • Nonsplint therapy

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.
  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544439

Contacts
Contact: Patricia R. Coelho, Master (32) 0032-1100 patriciacoelho.odonto@gmail.com

Locations
Brazil
Federal University of Juiz de Fora Recruiting
Juiz de Fora, Minas Gerais, Brazil, 36036-900
Contact: Patrícia R. Coelho    (32)9932-1100      
Principal Investigator: Patricia R. Coelho         
Sponsors and Collaborators
Patra-cia Rocha Coelho
Federal University of Juiz de Fora
Investigators
Principal Investigator: Patricia R. Coelho, Master Federal University of Juiz de Fora
  More Information

Additional Information:
Publications:

Responsible Party: Patra-cia Rocha Coelho, Principal Investigator, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT01544439     History of Changes
Other Study ID Numbers: UTN: U111-1128-3875, 0183.0.180.000-11, 199/2011
Study First Received: February 23, 2012
Last Updated: May 15, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Juiz de Fora:
Temporomandibular joint disorders
Stress psychological
Depression
Quality of Life

Additional relevant MeSH terms:
Jaw Diseases
Musculoskeletal Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 20, 2014