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

  • Egypt
      • 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
Device: 3D printed mitchigen appliance
the process of appliance construction done by intra-oral scanning of the arch and 3d printing
Active Comparator: side chair appliance
Device: 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

Fayoum University

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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