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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04455672

Enrollment

Registered

2020-07-02

Start date

2020-07-01

Completion date

2021-09-26

Last updated

2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder

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

Interventions

DEVICEsplints

* 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 .

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026