Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints

Not Applicable

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Other: Osteopathic Manipulative Treatment; Other: Sham intervention

• Registration Number: NCT02991326
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Primary Completion: 2018-12
• Status Verified: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• individuals who has diagnosis of Temporomandibular disorder.

Exclusion Criteria

• individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group (TG)	Osteopathic Manipulative Treatment	The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.
Control Group (CG)	Sham intervention	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).

Primary Outcome Measures

Name	Time	Method
Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month	2 months	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

Name	Time	Method
Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months	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	2 months	The use of SF36 to measure the score of quality of life before and 2 months after first intervention.

Trial Locations

Locations (1)

Federal Fuminense University; 🇧🇷 Niteroi, RJ, Brazil