Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

Not Applicable

Completed

• Conditions: Muscle Disorder
• Interventions: Device: digital stabilizing splint

• Registration Number: NCT06138535
• Lead Sponsor: zahraa hassan

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.

Study Timeline

• Study Start: 2022-09-30
• Primary Completion: 2023-10-30
• Status Verified: 2023-11
• Study Completion: 2023-11-10
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Masticatory Muscle Disorder patients treated by digital stabilizing splint	digital stabilizing splint	digital stabilizing splint

Primary Outcome Measures

Name	Time	Method
Patient questionnaire (clinical symptoms).	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 Outcome Measures

Name	Time	Method
Clinical sign such as mouth opening	3 months	Clinical sign such as mouth opening that was recorded by measuring the distance between the upper and lower central incisors by a caliper in millimeters unit.; the increase in mouth opening indicates positive clinical improvement. the mouth opening was measured before and after 3 months of treatment.

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Egypt