- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959174
Evaluation of 3D Michigan Appliance
April 15, 2024 updated by: Shaimaa Mohsen, Fayoum University
Development of Algorithm for 3d Printed Michigan Appliances in Patients With Temporomandibular Disorders
- 20 patients will be divided into 2 groups
- Group 1 : in which conventional appliance will be constructed after alginate impression
- Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Shaimaa Refahee
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient with bruxism
- Trigger points
- Medically stable
Exclusion Criteria:
- • absence of other TMJ problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 3d printed appliance
|
the process of appliance construction done by intra-oral scanning of the arch and 3d printing
|
Active Comparator: side chair appliance
|
the impresion will be taken to make a cast to reconstruct the appliance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogue scale
Time Frame: Change from immediate postoperative to 6 months
|
pain assessment by visual analog scale (0-10) as 0 means no pain and 10 means severe pain immediately postoperative and 6 months later
|
Change from immediate postoperative to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2023
Primary Completion (Estimated)
April 28, 2024
Study Completion (Estimated)
May 30, 2024
Study Registration Dates
First Submitted
July 17, 2023
First Submitted That Met QC Criteria
July 24, 2023
First Posted (Actual)
July 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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