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Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional Group
Osteopathic Group
Ibuprofen
Cyclobenzaprine Hydrochloride
Sponsored by
Instituto Brasileiro de Osteopatia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Temporomandibular Disorder, Osteopathic Manipulative Treatment, Rigid Splint, Speech Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment.

Exclusion Criteria:

  • continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.

Sites / Locations

  • Brazilian Institute of Osteopathy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Group

Osteopathic Group

Arm Description

Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.

Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).

Outcomes

Primary Outcome Measures

Pain intensity
Pain assessed by visual analogue scale.

Secondary Outcome Measures

(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders

Full Information

First Posted
November 16, 2016
Last Updated
November 22, 2016
Sponsor
Instituto Brasileiro de Osteopatia
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1. Study Identification

Unique Protocol Identification Number
NCT02974166
Brief Title
Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders
Official Title
Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Brasileiro de Osteopatia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether osteopathic manipulative treatment associated to Dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.
Detailed Description
A standardized TMD examination was executed in all patients by a dentist following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten items clinical exam. All these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and the second, as Axis II propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile. Others assessment instruments utilized on the research were the VAS consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal vertical distance of the incisors. The subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. The masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. The statistical analysis was performed using the means comparisons for the parametric tests through Student T test and for the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with frequencies analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Temporomandibular Disorder, Osteopathic Manipulative Treatment, Rigid Splint, Speech Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.
Arm Title
Osteopathic Group
Arm Type
Experimental
Arm Description
Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).
Intervention Type
Other
Intervention Name(s)
Conventional Group
Intervention Description
Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.
Intervention Type
Other
Intervention Name(s)
Osteopathic Group
Intervention Description
Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
anti-inflammatory drug
Intervention Description
The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine Hydrochloride
Other Intervention Name(s)
muscle relaxer
Intervention Description
The medication was prescribed by the dentist as muscle relaxer if necessary.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain assessed by visual analogue scale.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment. Exclusion Criteria: continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thiago B Susin
Organizational Affiliation
IBO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazilian Institute of Osteopathy
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

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