- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04374682
Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome
Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome: A Pilot Study in a Tertiary Care Hospital.
Study Overview
Detailed Description
Each patient was seen by the rheumatologist who did the following; Full history taking including special habits like chewing gums or biting nails, Pain level measured by visual analogue scale 100 (both at rest and during temporomandibular joint movement) Clinical Examination of the temporomandibular joint including localized tenderness and amount of mouth opening After that the patients were prescribed the rehabilitation program in the form of heat modalities and Transcutaneous electric nerve stimulation on the on the temporomandibular joint, given an individual demonstration of the home based exercises and were given a reminding handout.
The rehabilitation program consisted of the following exercises: lateral deviation, protrusion/retraction and mandibular opening.
Isometric cervical muscle strengthening exercises were also prescribed for the patients.
Assessment of the severity of temporomandibular joint affection using the Fonseca's questionnaire were done twice; the first at the entry point to the study and once again after 6 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients suffering painful temporomandibular joint
Exclusion Criteria:
- Patients with history of face trauma
- Patients with surgery at the temporomandibular joint
- Dental procedure in the last 6 months period
- Patients with rheumatic diseases
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogue scale for pain during rest and on moving the jaw
Time Frame: 6 months
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visual analogue scale 0-100 with higher score indicating more pain.
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6 months
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mouth opening
Time Frame: 6 months
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Distance between the edges of central incisors was measured.
Measures are compared pre and post exercises.
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6 months
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Fonseca's scale.
Time Frame: 6 months
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It is composed of 10 questions, which include checking for the presence of pain in temporomandibular joint, head, back, and while chewing, parafunctional habits, movement limitations, joint clicking, perception of malocclusion, and sensation of emotional stress.
The volunteers were informed that the 10 questions should be answered with "yes", "no" and "sometimes" and that only one answer should be marked for each question.
Scoring ranges between 0-50 with higher score indicating worse results.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Safaa A Mahran, MD, Assiut University
Publications and helpful links
General Publications
- Eweka OM, Ogundana OM, Agbelusi GA. TEMPOROMANDIBULAR PAIN DYSFUNCTION SYNDROME IN PATIENTS ATTENDING LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS, NIGERIA. J West Afr Coll Surg. 2016 Jan-Mar;6(1):70-87.
- Kato MT, Kogawa EM, Santos CN, Conti PC. TENS and low-level laser therapy in the management of temporomandibular disorders. J Appl Oral Sci. 2006 Apr;14(2):130-5. doi: 10.1590/s1678-77572006000200012.
- Cascos-Romero J, Vazquez-Delgado E, Vazquez-Rodriguez E, Gay-Escoda C. The use of tricyclic antidepressants in the treatment of temporomandibular joint disorders: systematic review of the literature of the last 20 years. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E3-7.
- Carvalho CM, de Lacerda JA, dos Santos Neto FP, Cangussu MC, Marques AM, Pinheiro AL. Wavelength effect in temporomandibular joint pain: a clinical experience. Lasers Med Sci. 2010 Mar;25(2):229-32. doi: 10.1007/s10103-009-0695-y. Epub 2009 Jun 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17300389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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