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Evaluation of 3D Michigan Appliance

Primary Purpose

Myofacial Pain Syndromes

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

3D printed mitchigen appliance

side chair appliance

About this trial

This is an interventional treatment trial for Myofacial Pain Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with bruxism Trigger points Medically stable Exclusion Criteria: • absence of other TMJ problem

Sites / Locations

Shaimaa Refahee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

3d printed appliance

side chair appliance

Arm Description

Outcomes

Primary Outcome Measures

visual analogue scale

pain assessment by visual analogue scale immediate postoperative and 6 months later

Secondary Outcome Measures

Full Information

NCT ID

NCT05959174

First Posted

July 17, 2023

Last Updated

July 24, 2023

Sponsor

Fayoum University

1. Study Identification

Unique Protocol Identification Number

NCT05959174

Brief Title

Evaluation of 3D Michigan Appliance

Official Title

Development of Algorithm for 3d Printed Michigan Appliances in Patients With Temporomandibular Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 15, 2023 (Actual)

Primary Completion Date

December 28, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofacial Pain Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

3d printed appliance

Arm Type

Active Comparator

Arm Title

side chair appliance

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

3D printed mitchigen appliance

Intervention Description

the process of appliance construction done by intra-oral scanning of the arch and 3d printing

Intervention Type

Device

Intervention Name(s)

side chair appliance

Intervention Description

the impresion will be taken to make a cast to reconstruct the appliance

Primary Outcome Measure Information:

Title

visual analogue scale

Description

pain assessment by visual analogue scale immediate postoperative and 6 months later

Time Frame

Change from immediate postoperative to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with bruxism Trigger points Medically stable Exclusion Criteria: • absence of other TMJ problem

Facility Information:

Facility Name

Shaimaa Refahee

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Evaluation of 3D Michigan Appliance

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