NCT06138535

Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: zahraa hassan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

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.

Conditions

• Muscle Disorder

Interventions

Type	Name	Description
DEVICE	digital stabilizing splint	3D Printed stabilizing splint that has been digitally designed on a modern software

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-10-30
• Completion: 2023-11-10
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Egypt