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

NCT04455672 | Unknown DMC

• 1 other identifier: CEBD-CU-2020-06-29
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• pain relief

  questionnaire will be used to evaluate the pain

  6 months

Study Arms (2)

interventional group

EXPERIMENTAL

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

Device: splints

control group

ACTIVE COMPARATOR

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

Device: splints

Interventions

splints 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; interventional group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the principle investigator

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: July 1, 2020
• Primary Completion: July 26, 2021
• Study Completion: September 26, 2021
• Last Updated: July 2, 2020

Record last verified: 2020-06