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Completed

NCT Number: NCT06138535

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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Azhar University

Cairo, 11765, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Stabilizing Splint

Device

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

Other names: occlusal splint

Primary outcomes

  1. Patient questionnaire (clinical symptoms).

    Time frame: 3 months

    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.

Secondary outcomes

  1. Clinical sign such as mouth opening

    Time frame: 3 months

    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.

Other outcomes

  1. Evaluation of muscle activation with surface electromyography (EMG)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

zahraa hassan

Other

Collaborators

  • Al-Azhar University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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