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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991326
• Other study ID #: Simone Oliveira
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• individuals who has diagnosis of Temporomandibular disorder.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Disease
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• 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;
• 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.

Locations

Country	Name	City	State
Brazil	Federal Fuminense University	Niteroi	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months