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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Temporomandibular Disorder

Treatments

Device: splints

Study type

Interventional

Funder types

Other

Identifiers

NCT04455672
CEBD-CU-2020-06-29

Details and patient eligibility

About

• 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

Enrollment

24 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

interventional group
Experimental group
Description:
patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)
Treatment:
Device: splints
control group
Active Comparator group
Description:
patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)
Treatment:
Device: splints

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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