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NCT04591899 Clinical Trial

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

Temporomandibular Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04591899
Other study ID # 23091988
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2023
Est. completion date June 2024

Study information
Verified date August 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• CAD/CAM splints
Each of the maxillary and mandibular cast will scanned alone and then both scanned together in the centric relation using FREEDOM HD scanner1. The CAD/ CAM splint will be designed using Exocad software; the design will be the same as the conventional one. The surveying will be done by the software and the under-cuts blocked. The splints will be printed using Dent2 3D printer and then cured using Dentcure. The CAD/CAM splints material will be hard resin from PhotoCentric 3D.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Satisfaction, done by questionnaire having the visual analogue scale 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. 3 months
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