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Clinical Trials/NCT06138535
NCT06138535
Completed
Not Applicable

Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

zahraa hassan1 site in 1 country8 target enrollmentSeptember 30, 2022
ConditionsMuscle Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Disorder
Sponsor
zahraa hassan
Enrollment
8
Locations
1
Primary Endpoint
Patient questionnaire (clinical symptoms).
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are:

• is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be asked to ware the splint and progressively increasing the duration of splint wear, starting from 8 hours per day for 3 months .

Detailed Description

The current research was conducted for evaluation of the digital stabilizing splint in the management of masticatory muscle disorder. Subjects and Methods: Eight patients over the age of 18 with masticatory muscle disorders received treatment using a stabilizing splint that was digitally created. The Each patient's response to therapy modifications was assessed and compared before and after splint insertion for each patient subjective symptoms were assessed using a patient questionnaire that was repeated before treatment (baseline), one month, and 3 months post-insertion. Moreover, The masseter and temporalis muscles' electrical activity was measured using electromyography at baseline and after three months.post-splint insertion. Clinical signs such as mouth-opening lateral movements and protrusive movements were measured before and 3 months after the splint was inserted.

Registry
clinicaltrials.gov
Start Date
September 30, 2022
End Date
November 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
zahraa hassan
Responsible Party
Sponsor Investigator
Principal Investigator

zahraa hassan

Principal Investigator

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient questionnaire (clinical symptoms).

Time Frame: 3 months

Patient questionnaire (clinical symptoms) . The questionnaire was used to detect the clinical symptoms scoring that ranges from 0 to 10 (10 being greatest pain/dysfunction and 0 signifying no pain/proper function). The success or failure was determined by the reduction in pain and dysfunction postoperatively. the scales were taken for all eight patients before and after 3 months of treatment. the questionnaire included questions about different clinical symptoms as following: headaches, facial discomfort, jaw joint pain, pain during mastication, neck pain, difficulty opening the mouth, difficulty in jaw movements, complaints during chewing, and clenching habits.

Secondary Outcomes

  • Clinical sign such as mouth opening(3 months)

Study Sites (1)

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