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

Primary Purpose

Temporomandibular Disorder

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CAD/CAM splints

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAD/CAM SS

Conventionally manufactured SS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04591899

First Posted

October 4, 2020

Last Updated

August 2, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04591899

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAD/CAM SS

Arm Type

Experimental

Arm Title

Conventionally manufactured SS

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

CAD/CAM splints

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patient Satisfaction, done by questionnaire having the visual analogue scale

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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