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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04455672
• Other study ID #: CEBD-CU-2020-06-29
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: September 26, 2021

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief	questionnaire will be used to evaluate the pain	6 months