Clinical trial NCT02991326: 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
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: Osteopathic Manipulative Treatment
Temporomandibular Disorder
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month
timeFrame: 2 months
Secondary outcomes:
measure: Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months
timeFrame: 2 months
measure: Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months
timeFrame: 2 months
Other outcomes:
Locations:
city: Niteroi
country: Brazil
facility: Federal Fuminense University
state: RJ
Study officials:
affiliation: Federal Fluminense University
name: Felipe RT Goulart, Graduated
role: PRINCIPAL_INVESTIGATOR
References: