Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Sham intervention
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Osteopathic Manipulative Treatment, Temporomandibular Disorder
Eligibility Criteria
Inclusion Criteria:
- individuals who has diagnosis of Temporomandibular disorder.
Exclusion Criteria:
- individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.
Sites / Locations
- Federal Fuminense University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Test Group (TG)
Control Group (CG)
Arm Description
The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.
The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).
Outcomes
Primary Outcome Measures
Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month
The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.
Secondary Outcome Measures
Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months
The use of Numeric Rating Scale (NRS) to measure de pain intensity in the body area with the most intensity pain related by the individuals before and 2 months after first intervention.
Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months
The use of SF36 to measure the score of quality of life before and 2 months after first intervention.
Full Information
NCT ID
NCT02991326
First Posted
December 7, 2016
Last Updated
May 16, 2019
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT02991326
Brief Title
Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints
Official Title
Osteopathic Manipulative Treatment Effect in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aim to contribute with the investigation of the therapeutic effect of osteopathic manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with temporomandibular disorder who make use of occlusal splints.
Detailed Description
Objective:
It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the need of a multidisciplinary approach for its treatment. Studies have presented good results about the use of occlusal splints along with other therapies. The Osteopathic Manipulative Treatment(OMT) has as characteristic the philosophy of global approach and precise functional diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality of Life in participants diagnosed with TMD making use of occlusal splints.
Methodology:
This study is a randomized blind trial, with sample composed by 18 participants referred to the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of dentists and interns of occlusion clinic through the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36 Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham treatment that simulate the OMT to blind these participants. After the treatment, patients will be re-evaluated in 8 weeks' time.
Statistical analysis:
The SF-36 and the pain intensity and the most intense pain evaluation diagram with Numeric Rating Scale (NRS) will be performed by the Wilcoxon's non parametric test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Osteopathic Manipulative Treatment, Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group (TG)
Arm Type
Experimental
Arm Description
The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.
Arm Title
Control Group (CG)
Arm Type
Sham Comparator
Arm Description
The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
The Osteopathic manipulative treatment will follow the approach bellow (using latex gloves for intra oral techniques):
Compression of the fourth ventricle;
inhibitory intra-oral pressure technique (IPT) of the temporal muscle;
inhibition of the inferior head of the lateral pterygoid muscle;
intra-oral inhibition of the masseter muscle;
Balanced ligamentous tension (BLT) of the accessory ligaments - sphenopalatine;
BLT of the accessory ligaments - pterygomandibular raphe;
sphenopalatine ganglion technique;
Craniosacral rebalancing;
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
The sham intervention will be made in the same examination table and the same position, with the use of the latex gloves, to simulate the Osteopathic Manipulative Treatment, only doing simple touches without therapeutic effect intention.
Primary Outcome Measure Information:
Title
Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month
Description
The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months
Description
The use of Numeric Rating Scale (NRS) to measure de pain intensity in the body area with the most intensity pain related by the individuals before and 2 months after first intervention.
Time Frame
2 months
Title
Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months
Description
The use of SF36 to measure the score of quality of life before and 2 months after first intervention.
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
individuals who has diagnosis of Temporomandibular disorder.
Exclusion Criteria:
individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe RT Goulart, Graduated
Organizational Affiliation
Federal Fluminense University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Fuminense University
City
Niteroi
State/Province
RJ
ZIP/Postal Code
24020-140
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints
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