Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

Conditions
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Muscle Disorder

Intervention / Treatment
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* Device: digital stabilizing splint


Participation Criteria
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Eligibility Criteria
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inclusion criteria 1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria Absence of previous occlusal splint therapy. Absence of apparent dental or periodontal diseases. Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded. Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome. Patients with multiple teeth loss that affects occlusal splint support were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single arm group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Masticatory Muscle Disorder patients treated by digital stabilizing splint<br>digital stabilizing splint | Device: digital stabilizing splint<br>* 3D Printed stabilizing splint that has been digitally designed on a modern software<br>* Other names: occlusal splint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaire (clinical symptoms). | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sign such as mouth opening | 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. | 3 months |