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

NCT ID: NCT04455672

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-09-26

Brief Summary

• 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

Conditions

Temporomandibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interventional group

patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)

Group Type: EXPERIMENTAL

splints

Intervention Type: DEVICE

• 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 .

control group

patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)

Group Type: ACTIVE_COMPARATOR

splints

Intervention Type: DEVICE

• 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 .

Interventions

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 .

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

mostafa mohamed sobhy

the principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CEBD-CU-2020-06-29

Identifier Type: -

Identifier Source: org_study_id