A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder

A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder (A Randomized Cross Over Clinical Trial)

• to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints followed by a stabilizing splints

Study Overview

• Status: Unknown
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Device: splints

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• • TMDs according to the research diagnostic criteria (RDC)8 which include: i. Painful TMJ audible and palpable click unilateral or bilateral ii. Presence of clicking during opening. iii. TMJ tenderness.

  • Fully dentate patients without any malocclusion (natural or restored by fixed prothesis) 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 taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
  • Patients with removable dental prosthesis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional group; patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)	Device: splints; Scaning of the maxillary and mandibular cast in the centric relation.; The CAD/ CAM splints will be designed using Exocad s.; The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth.; The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp.; Both splints will be printed using Dent2 3D printer and then cured using Dentcure.; All patient will be asked to wear their spints during sleeping only.; In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months .
Active Comparator: control group; patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)	Device: splints; Scaning of the maxillary and mandibular cast in the centric relation.; The CAD/ CAM splints will be designed using Exocad s.; The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth.; The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp.; Both splints will be printed using Dent2 3D printer and then cured using Dentcure.; All patient will be asked to wear their spints during sleeping only.; In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief	questionnaire will be used to evaluate the pain	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 26, 2021
• Study Completion (Anticipated): September 26, 2021

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: CEBD-CU-2020-06-29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No