Back to resultsPrefabricated Versus 3D-Printing Myofunctional Appliances
Primary Purpose
Class II Division 1 Malocclusion
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
3d-Printing Myofunctional Appliance
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Myofunctional treatment, 3D-Print, Prefabricated myofunctional appliance, Class II division 1 malocclusion, Orthodontics
Eligibility Criteria
Inclusion Criteria:
- Increased overjet >4 mm
- Skeletal Class II relationship (ANB > 4 degree)
- No previous orthodontic treatment
Exclusion Criteria:
-Craniofacial syndrome
Sites / Locations
- Ordu UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
3D-print myofunctional appliance
Prefabricated myfunctional appliance
Outcomes
Primary Outcome Measures
Rate of dentoskeletal changes
Dentoskeletal effects of appliances
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04810286
Brief Title
Prefabricated Versus 3D-Printing Myofunctional Appliances
Official Title
Comparison of Prefabricated Myofunctional Appliances and 3D-Printing Myofunctional Appliances in Children With Class II Division 1 Malocclusion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this clinical study is to evaluate the dentoskeletal effects of Class II division 1 treatment in growing patients with a prefabricated myofunctional appliance versus a 3D-printing myofunctional appliance.
Detailed Description
This study aims to investigate the dentoskeletal effects of Class II division 1 treatment in growing patients with a prefabricated myofunctional appliance versus a 3D-printing myofunctional appliance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Myofunctional treatment, 3D-Print, Prefabricated myofunctional appliance, Class II division 1 malocclusion, Orthodontics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
3D-print myofunctional appliance
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Prefabricated myfunctional appliance
Intervention Type
Procedure
Intervention Name(s)
3d-Printing Myofunctional Appliance
Intervention Description
To evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance.
Primary Outcome Measure Information:
Title
Rate of dentoskeletal changes
Description
Dentoskeletal effects of appliances
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Increased overjet >4 mm
Skeletal Class II relationship (ANB > 4 degree)
No previous orthodontic treatment
Exclusion Criteria:
-Craniofacial syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suleyman Kutalmış Buyuk, PhD
Phone
+904522121286
Ext
7216
Email
skbuyuk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huseyin Simsek, PhD
Phone
+904522121286
Ext
7165
Email
dr.huseyinsimsek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suleyman Kutalmış Buyuk, PhD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Study Chair
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suleyman Kutalmış Buyuk, PhD
Phone
+904522121286
Ext
7216
Email
skbuyuk@gmail.com
First Name & Middle Initial & Last Name & Degree
Huseyin Simsek, PhD
Phone
+904522121286
Ext
7165
Email
dr.huseyinsimsek@gmail.com
First Name & Middle Initial & Last Name & Degree
Suleyman Kutalmış Buyuk, phD
12. IPD Sharing Statement
Plan to Share IPD
No
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Prefabricated Versus 3D-Printing Myofunctional Appliances
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