Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

Muscle Disorder Clinical Trial

Official title:

Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138535
• Other study ID #: AZJD-D-23-00044
• Status: Completed
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 10, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

inclusion criteria

1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria

1. Absence of previous occlusal splint therapy.

2. Absence of apparent dental or periodontal diseases.

3. Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded.

4. Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome.

5. Patients with multiple teeth loss that affects occlusal splint support were excluded.

Related Conditions & MeSH terms

• Muscle Disorder
• Muscular Diseases

Intervention

Device:
• digital stabilizing splint
3D Printed stabilizing splint that has been digitally designed on a modern software

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
zahraa hassan	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of muscle activation with surface electromyography (EMG)	Evaluation of muscle activation with surface electromyography (EMG) for each of the eight patients enrolled in our study, and the records were taken before and after 3 months of treatment.; The surface electrodes were placed on the anterior temporalis and the superficial masseter muscles.; A Fast Fourier Transform ( FFT ) was carried out using the software of electromyography. The mean value of the EMG activity of each muscle was calculated from the amplitude in microvolts ( µV ).; The decrease in the muscle records was an indication of improvement of muscle activity.	3 months
Primary	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	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

External Links

•   Al-Azhar Journal of Dentistry