Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

NCT06138535 | Completed DMC

• 1 other identifier: AZJD-D-23-00044
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 .

Conditions

Muscle Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical sign such as mouth opening

  3 months

Other Outcomes (1)

• Evaluation of muscle activation with surface electromyography (EMG)

  3 months

Study Arms (1)

Masticatory Muscle Disorder patients treated by digital stabilizing splint

OTHER

digital stabilizing splint

Device: digital stabilizing splint

Interventions

digital stabilizing splint DEVICE

3D Printed stabilizing splint that has been digitally designed on a modern software

Also known as: occlusal splint

Masticatory Muscle Disorder patients treated by digital stabilizing splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• zahraa hassan: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al Azhar University

Cairo, 11765, Egypt

Location

MeSH Terms

Conditions

Muscular Diseases

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• zahraa hassan

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single arm group study

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: September 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 10, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: one yaer
• Access Criteria: Al-Azhar Journal of Dentistry

Locations

EG (1)