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Occlusal Splint and Counseling to Temporomandibular Disorder

Primary Purpose

Temporomandibular Disorders, Stress Psychological, Musculoskeletal Diseases

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
stabilizing appliance
Non-occluding splint, counseling
Sponsored by
Patra-cia Rocha Coelho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Temporomandibular joint disorders, Stress psychological, Depression, Quality of Life

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Juiz de ForaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral stabilization appliance,counselling

Non-occluding splint, counselling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Evaluation of psycho-emotional aspects related to the TMD
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).

Full Information

First Posted
February 23, 2012
Last Updated
May 15, 2012
Sponsor
Patra-cia Rocha Coelho
Collaborators
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT01544439
Brief Title
Occlusal Splint and Counseling to Temporomandibular Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patra-cia Rocha Coelho
Collaborators
Federal University of Juiz de Fora

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders, Stress Psychological, Musculoskeletal Diseases
Keywords
Temporomandibular joint disorders, Stress psychological, Depression, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral stabilization appliance,counselling
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-occluding splint, counselling
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
stabilizing appliance
Other Intervention Name(s)
Occlusal stabilization appliance, Oral splints, Stabilization splint theraphy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-occluding splint, counseling
Other Intervention Name(s)
Splint control, Nonsplint therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of physical symptoms
Description
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.
Time Frame
Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks.
Title
Assessment of Quality of Life related to TMD
Description
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).
Time Frame
Participants will be monitored during the study period to assess changes in quality of life in 12 weeks
Secondary Outcome Measure Information:
Title
Evaluation of psycho-emotional aspects related to the TMD
Description
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).
Time Frame
The psycho-emotional aspects will be evaluated before and after the intervention period of three months (12 weeks) to initiation of therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia R. Coelho, Master
Phone
(32) 0032-1100
Email
patriciacoelho.odonto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia R. Coelho, Master
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Juiz de Fora
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36036-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrícia R. Coelho
Phone
(32)9932-1100
First Name & Middle Initial & Last Name & Degree
Patricia R. Coelho

12. IPD Sharing Statement

Citations:
PubMed Identifier
18976268
Citation
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.
Results Reference
result
PubMed Identifier
8159444
Citation
Dao 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.
Results Reference
result
PubMed Identifier
12756930
Citation
De 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.
Results Reference
result
PubMed Identifier
12836501
Citation
Ekberg 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.
Results Reference
result
PubMed Identifier
16040444
Citation
Jokstad 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.
Results Reference
result
PubMed Identifier
17717958
Citation
Riley 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.
Results Reference
result
PubMed Identifier
16873325
Citation
Truelove 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.
Results Reference
result
PubMed Identifier
7488989
Citation
Wright 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.
Results Reference
result
Links:
URL
http://portal2.saude.gov.br/sisnep/extrato_projeto.cfm?CODIGO=443975
Description
Page SISNEP where they found information about the submission and approval of the study to the Platform Brazil - the Ethics in Human Research - Dean of Research / UFJF

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Occlusal Splint and Counseling to Temporomandibular Disorder

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