NCT04810286

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 17, 2021

Last Update Submit

March 19, 2021

Conditions

Class II Division 1 Malocclusion

Keywords

Myofunctional treatment3D-PrintPrefabricated myofunctional applianceClass II division 1 malocclusionOrthodontics

Outcome Measures

Primary Outcomes (1)

  • Rate of dentoskeletal changes

    Dentoskeletal effects of appliances

    1 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

3D-print myofunctional appliance

Procedure: 3d-Printing Myofunctional Appliance

Control Group

ACTIVE COMPARATOR

Prefabricated myfunctional appliance

Procedure: 3d-Printing Myofunctional Appliance

Interventions

3d-Printing Myofunctional AppliancePROCEDURE

To evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance.

Control GroupExperimental Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Craniofacial syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Suleyman Kutalmış Buyuk, PhD

    Ordu University

    STUDY CHAIR

Central Study Contacts

Suleyman Kutalmış Buyuk, PhD

CONTACT

+904522121286skbuyuk@gmail.com

Huseyin Simsek, PhD

CONTACT

+904522121286dr.huseyinsimsek@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 22, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

November 1, 2023

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)