Back to resultsA Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder
Primary Purpose
Temporomandibular Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
splints
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
interventional group
control group
Arm Description
patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)
patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)
Outcomes
Primary Outcome Measures
pain relief
questionnaire will be used to evaluate the pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04455672
Brief Title
A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder
Official Title
A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder (A Randomized Cross Over Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 26, 2021 (Anticipated)
Study Completion Date
September 26, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional group
Arm Type
Experimental
Arm Description
patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint)
Intervention Type
Device
Intervention Name(s)
splints
Intervention Description
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 .
Primary Outcome Measure Information:
Title
pain relief
Description
questionnaire will be used to evaluate the pain
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder
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