Occlusal Splint and Counseling to Temporomandibular Disorder
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
3 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 17, 2012
March 1, 2012
2 months
February 23, 2012
May 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of physical symptoms
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.
Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks.
Assessment of Quality of Life related to TMD
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).
Participants will be monitored during the study period to assess changes in quality of life in 12 weeks
Secondary Outcomes (1)
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
Study Arms (2)
Oral stabilization appliance,counselling
EXPERIMENTALThe 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
PLACEBO COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Patra-cia Rocha Coelholead
- Federal University of Juiz de Foracollaborator
Study Sites (1)
Federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36036-900, Brazil
Related Publications (8)
Alencar F Jr, Becker A. Evaluation of different occlusal splints and counselling in the management of myofascial pain dysfunction. J Oral Rehabil. 2009 Feb;36(2):79-85. doi: 10.1111/j.1365-2842.2008.01913.x. Epub 2008 Oct 22.
PMID: 18976268RESULTDao TTT, Lavigne GJ, Charbonneau A, Feine JS, Lund JP. The efficacy of oral splints in the treatment of myofascial pain of the jaw muscles: a controlled clinical trial. Pain. 1994 Jan;56(1):85-94. doi: 10.1016/0304-3959(94)90153-8.
PMID: 8159444RESULTDe Laat A, Stappaerts K, Papy S. Counseling and physical therapy as treatment for myofascial pain of the masticatory system. J Orofac Pain. 2003 Winter;17(1):42-9.
PMID: 12756930RESULTEkberg E, Vallon D, Nilner M. The efficacy of appliance therapy in patients with temporomandibular disorders of mainly myogenous origin. A randomized, controlled, short-term trial. J Orofac Pain. 2003 Spring;17(2):133-9.
PMID: 12836501RESULTJokstad A, Mo A, Krogstad BS. Clinical comparison between two different splint designs for temporomandibular disorder therapy. Acta Odontol Scand. 2005 Aug;63(4):218-26. doi: 10.1080/00016350510019982.
PMID: 16040444RESULTRiley JL 3rd, Myers CD, Currie TP, Mayoral O, Harris RG, Fisher JA, Gremillion HA, Robinson ME. Self-care behaviors associated with myofascial temporomandibular disorder pain. J Orofac Pain. 2007 Summer;21(3):194-202.
PMID: 17717958RESULTTruelove E, Huggins KH, Mancl L, Dworkin SF. The efficacy of traditional, low-cost and nonsplint therapies for temporomandibular disorder: a randomized controlled trial. J Am Dent Assoc. 2006 Aug;137(8):1099-107; quiz 1169. doi: 10.14219/jada.archive.2006.0348.
PMID: 16873325RESULTWright E, Anderson G, Schulte J. A randomized clinical trial of intraoral soft splints and palliative treatment for masticatory muscle pain. J Orofac Pain. 1995 Spring;9(2):192-9.
PMID: 7488989RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia R. Coelho, Master
Federal University of Juiz de Fora
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 23, 2012
First Posted
March 6, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
May 17, 2012
Record last verified: 2012-03