Skip to main content
OpenTrials
Completed

NCT Number: NCT02991326

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal Fuminense University

Niterói, Rio de Janeiro, 24020-140, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • individuals who has diagnosis of Temporomandibular disorder.

Exclusion criteria

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

Treatment and study plan

Osteopathic manipulative treatment

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;

Sham intervention

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.

Primary outcomes

  1. Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month

    Time frame: 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 outcomes

  1. Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months

    Time frame: 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. Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months

    Time frame: 2 months

    The use of SF36 to measure the score of quality of life before and 2 months after first intervention.

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 13, 2016
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.