Skip to main content
OpenTrials
Completed

NCT Number: NCT02974166

Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

The purpose of this study is to determine whether osteopathic manipulative treatment associated to Dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.

Completed

Looking for future studies?

Notify Me

Key information

About this study

A standardized TMD examination was executed in all patients by a dentist following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten items clinical exam. All these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and the second, as Axis II propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile.

Others assessment instruments utilized on the research were the VAS consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal vertical distance of the incisors. The subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. The masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. The statistical analysis was performed using the means comparisons for the parametric tests through Student T test and for the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with frequencies analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment.

Exclusion criteria

  • continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.

Treatment and study plan

Conventional Group

Other

Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.

Osteopathic Group

Other

Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.

Ibuprofen

Drug

The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.

Other names: anti-inflammatory drug

Cyclobenzaprine Hydrochloride

Drug

The medication was prescribed by the dentist as muscle relaxer if necessary.

Other names: muscle relaxer

Primary outcomes

  1. Pain intensity

    Time frame: 4 weeks

    Pain assessed by visual analogue scale.

Secondary outcomes

  1. (RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Instituto Brasileiro de Osteopatia

Other

Registry information

Official study title

Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Nov 28, 2016
Registry last updated
Nov 28, 2016

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.

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