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

NCT ID: NCT04591899

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CAD/CAM SS

Group Type EXPERIMENTAL

CAD/CAM splints

Intervention Type DEVICE

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.

Conventionally manufactured SS

Group Type ACTIVE_COMPARATOR

CAD/CAM splints

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maram Ahmed Taema

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23091988

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation Lingual Ring Splint
NCT03000790 UNKNOWN NA