Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction

NCT04557878

Temporomandibular Joint Disorders Temporomandibular Disorder

COMPLETED PHASE2

Treatment of Excessive Gingival Display (Lip Repositioning and Z Plasty)

NCT07334015

Excessive Gingival Display

COMPLETED NA

Computed Guided Prolotherapy Versus Conventional Prolotherapy

NCT06132594

Temporomandibular Joint Disorders Orofacial Pain

COMPLETED NA

Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

NCT06441279

TMJ Disc Disorder

COMPLETED NA

I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement

NCT06207955

TMJ Disc Disorder TMJ Pain

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

single arm group study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Masticatory Muscle Disorder patients treated by digital stabilizing splint

digital stabilizing splint

Group Type OTHER

digital stabilizing splint

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

digital stabilizing splint

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

occlusal splint

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No