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Completed

NCT Number: NCT02380105

Effectiveness of a Counseling Program for Temporomandibular Disorders (TMD) Treatment

This study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD).

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

In this study, 51 patients were allocated to one of the research groups. In Group I, it was instituted counseling therapy. For Group II was conducted treatment as usual with occlusal splint. Patients were followed for returns at 7, 15, 30 and 60 days after baseline. At baseline, all patients were examined and assessed Research Diagnostic Criteria/Temporomandibular Disorder (RDC/TMD form). In addition, the patients were referred for specific treatment according to the group to which belonged. In each session, patients were also surveyed about pain intensity using a Numeric Scale. To analyze the impact of pain on quality of life, Oral Health Impact Profile (OHIP-14) questionnaire was used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female individuals
  • Positive diagnosis of TMD according to RDC/TMD
  • Presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the Numeric Scale of pain

Exclusion criteria

  • TMD treatment for ongoing pain
  • Presence of pulpal or periodontal disease
  • Orthodontic treatment in progress
  • Daily use of analgesics, antidepressants or muscle relaxants
  • History of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved

Treatment and study plan

Counseling

Behavioral

Patients were informed of their condition and possible etiological factors contributing to the pathology. They were also educated about the postural rest position of the mandible and instructed to perform bilateral chewing and not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions for future reference, as a way of reinforcing the information provided during the initial consultation.

Interocclusal Appliances

Device

Patients were treated using interocclusal appliances

Primary outcomes

  1. Pain as measured by Visual Analogue Scale (VAS)

    Time frame: Baseline, 7, 15, 30, 60 days

    Visual Analogue Scale

Secondary outcomes

  1. Quality of life measured by Oral Health Impact Profile (OHIP)

    Time frame: Baseline, 7, 15, 30, 60 days

    Oral Health Impact Profile

  2. Functional Evaluation measured by TemporoMandibular Index (TMI)

    Time frame: Baseline, 7, 15, 30, 60 days

    Temporomandibular Index

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

Effectiveness of a Counseling Program for TMD Treatment

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 5, 2015
Registry last updated
Mar 5, 2015

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.

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