search
Back to results

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

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Counseling
Interocclusal Appliances
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Counseling Group

    Splint Group

    Arm Description

    Patients allocated to the counseling group (Group I) were informed about possible etiological factors and educated to 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, as a way of reinforcing the information provided during the initial consultation. In subsequent returns at 7, 15, 30 and 60 days of follow-up, the instructions were given again and patients were asked whether they had detected any habits related to the initiation and maintenance of painful symptoms of TMD, as a way to further highlight the association between the presence of these harmful behaviors and the worsening signs and symptoms of TMD.

    Patients allocated to the splint group (Group II) were treated using interocclusal appliances, according to the following protocol: At baseline, an anterior bite plate (front-plateau) was made from acrylic resin that was placed in the maxillary arch to include the the canine to canine region and promote the disocclusion of the posterior teeth. Patients were instructed to use the device for 24 hours, interspersed with rests of equal length during the first week. After 7 days, the device was removed. A hard splint was then made. At 30 days of follow-up, the splint was fitted and the patients were also asked to use it when they were sleeping.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Quality of life measured by Oral Health Impact Profile (OHIP)
    Oral Health Impact Profile
    Functional Evaluation measured by TemporoMandibular Index (TMI)
    Temporomandibular Index

    Full Information

    First Posted
    November 14, 2014
    Last Updated
    February 27, 2015
    Sponsor
    Universidade Federal do Rio Grande do Norte
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02380105
    Brief Title
    Effectiveness of a Counseling Program for Temporomandibular Disorders (TMD) Treatment
    Official Title
    Effectiveness of a Counseling Program for TMD Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Counseling Group
    Arm Type
    Experimental
    Arm Description
    Patients allocated to the counseling group (Group I) were informed about possible etiological factors and educated to 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, as a way of reinforcing the information provided during the initial consultation. In subsequent returns at 7, 15, 30 and 60 days of follow-up, the instructions were given again and patients were asked whether they had detected any habits related to the initiation and maintenance of painful symptoms of TMD, as a way to further highlight the association between the presence of these harmful behaviors and the worsening signs and symptoms of TMD.
    Arm Title
    Splint Group
    Arm Type
    Active Comparator
    Arm Description
    Patients allocated to the splint group (Group II) were treated using interocclusal appliances, according to the following protocol: At baseline, an anterior bite plate (front-plateau) was made from acrylic resin that was placed in the maxillary arch to include the the canine to canine region and promote the disocclusion of the posterior teeth. Patients were instructed to use the device for 24 hours, interspersed with rests of equal length during the first week. After 7 days, the device was removed. A hard splint was then made. At 30 days of follow-up, the splint was fitted and the patients were also asked to use it when they were sleeping.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Counseling
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Interocclusal Appliances
    Intervention Description
    Patients were treated using interocclusal appliances
    Primary Outcome Measure Information:
    Title
    Pain as measured by Visual Analogue Scale (VAS)
    Description
    Visual Analogue Scale
    Time Frame
    Baseline, 7, 15, 30, 60 days
    Secondary Outcome Measure Information:
    Title
    Quality of life measured by Oral Health Impact Profile (OHIP)
    Description
    Oral Health Impact Profile
    Time Frame
    Baseline, 7, 15, 30, 60 days
    Title
    Functional Evaluation measured by TemporoMandibular Index (TMI)
    Description
    Temporomandibular Index
    Time Frame
    Baseline, 7, 15, 30, 60 days

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs