Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

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 .

Study Overview

• Status: Completed
• Conditions: Muscle Disorder
• Intervention / Treatment: Device: digital stabilizing splint

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11765
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: zahraa hassan
• Collaborators: Al-Azhar University
• Investigators: Principal Investigator: zahraa hassan, Al-Azhar University

Publications and helpful links

Helpful Links

• Al-Azhar Journal of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: AZJD-D-23-00044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be obtained either from study investigators or via data-sharing repositories or platforms.
• IPD Sharing Time Frame: one yaer
• IPD Sharing Access Criteria: Al-Azhar Journal of Dentistry
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No