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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04374682
Other study ID # 17300389
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

patients with chronic refractory temporomandibular dysfunction were prescribed home exercise and were followed for 6 months. Pain , mouth opening and Fonseca's were done at day 1 and after 6 months of the study.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
exercises
stretching exercises - physiotherapy modalities - self care instructions

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Cascos-Romero J, Vázquez-Delgado E, Vázquez-Rodríguez 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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary visual analogue scale for pain during rest and on moving the jaw visual analogue scale 0-100 with higher score indicating more pain. 6 months
Primary mouth opening Distance between the edges of central incisors was measured. Measures are compared pre and post exercises. 6 months
Primary Fonseca's scale. 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. 6 months
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