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

NCT ID: NCT02991326

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-05-31

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.

Conditions

Temporomandibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Group (TG)

The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type: OTHER

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;

Control Group (CG)

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).

Group Type: SHAM_COMPARATOR

Sham intervention

Intervention Type: OTHER

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.

Interventions

Osteopathic Manipulative Treatment

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

Sham intervention

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Simone Saldanha Oliveira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe RT Goulart, Graduated

Role: PRINCIPAL_INVESTIGATOR

Federal Fluminense University

Locations

Federal Fuminense University

Niterói, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

Simone Oliveira

Identifier Type: -

Identifier Source: org_study_id