Clinical and Radiographic Outcomes of CAD/CAM vs Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders

Not Applicable

• Conditions: Temporomandibular Disorder
• Interventions: Device: CAD/CAM splints

• Registration Number: NCT04591899
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04
• Study Start: 2023-12
• Primary Completion: 2024-05
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD/CAM SS	CAD/CAM splints	-
Conventionally manufactured SS	CAD/CAM splints	-

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction, done by questionnaire having the visual analogue scale	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.