Prefabricated Versus 3D-Printing Myofunctional Appliances

March 19, 2021 updated by: Suleyman Kutalmış Buyuk, T.C. ORDU ÜNİVERSİTESİ

Comparison of Prefabricated Myofunctional Appliances and 3D-Printing Myofunctional Appliances in Children With Class II Division 1 Malocclusion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

  • Name: Suleyman Kutalmış Buyuk, PhD
  • Phone Number: 7216 +904522121286
  • Email: skbuyuk@gmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Ordu, Turkey, 52200
        • Recruiting
        • Ordu University
        • Contact:
          • Suleyman Kutalmış Buyuk, PhD
          • Phone Number: 7216 +904522121286
          • Email: skbuyuk@gmail.com
        • Contact:
        • Principal Investigator:
          • Suleyman Kutalmış Buyuk, phD

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Increased overjet >4 mm
  • Skeletal Class II relationship (ANB > 4 degree)
  • No previous orthodontic treatment

Exclusion Criteria:

-Craniofacial syndrome

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
Experimental: Experimental Group
3D-print myofunctional appliance
Procedure: 3d-Printing Myofunctional Appliance
To evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance.
Active Comparator: Control Group
Prefabricated myfunctional appliance
Procedure: 3d-Printing Myofunctional Appliance
To evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of dentoskeletal changes
Time Frame: 1 year
Dentoskeletal effects of appliances
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Investigators

  • Study Chair: Suleyman Kutalmış Buyuk, PhD, T.C. ORDU ÜNİVERSİTESİ

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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