Clinical and Radiographic Outcomes of CAD/CAM Versus Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders: A Randomized Clinical Trial

Cairo University0 sites20 target enrollmentDecember 2023

ConditionsTemporomandibular Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Temporomandibular Disorder
Sponsor: Cairo University
Enrollment: 20
Primary Endpoint: Patient Satisfaction, done by questionnaire having the visual analogue scale
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction

Registry

clinicaltrials.gov

Start Date

December 2023

End Date

June 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

Maram Ahmed Taema

Assistant Lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

•Patients' age ranging from 20 to 50 years.
•TMDs according to the research diagnostic criteria (RDC) for TMD (RDC/TMD) and magnetic resonance imaging (MRI) for confirmation which include:
•i. Painful TMJ audible and palpable click. ii. No functional mouth limitation. iii. TMJ tenderness. Fully dentate patients without any malocclusion and good oral hygiene. Co-operative patient that should show motivation to follow up.

Exclusion Criteria

•Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
•Patients showing bony irregularities e.g. osteophyte as recorded by Magnetic resonance imaging.
•Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
•Any condition that contra-indicates MRI such as patients with pacemakers in heart.
•Patients with removable dental prosthesis

Outcomes

Primary Outcomes

Patient Satisfaction, done by questionnaire having the visual analogue scale

Time Frame: 3 months

The questionnaire includes the following aspects; headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline 1 and 2 weeks after, then after 1,2 and 3 months. The questioner will be translated into Arabic language to be understood by the patients.