Evaluation of 3D Michigan Appliance

Myofacial Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05959174
• Other study ID #: 3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: May 30, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with bruxism

• Trigger points

• Medically stable

Exclusion Criteria:

• • absence of other TMJ problem

Related Conditions & MeSH terms

• Facial Neuralgia
• Facial Pain
• Myofacial Pain Syndromes

Intervention

Device:
• 3D printed mitchigen appliance
the process of appliance construction done by intra-oral scanning of the arch and 3d printing
• side chair appliance
the impresion will be taken to make a cast to reconstruct the appliance

Locations

Country	Name	City	State
Egypt	Shaimaa Refahee	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	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