Prefabricated Versus 3D-Printing Myofunctional Appliances

NCT ID: NCT04810286

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Class II Division 1 Malocclusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

3D-print myofunctional appliance

Group Type EXPERIMENTAL

3d-Printing Myofunctional Appliance

Intervention Type PROCEDURE

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

Control Group

Prefabricated myfunctional appliance

Group Type ACTIVE_COMPARATOR

3d-Printing Myofunctional Appliance

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

-Craniofacial syndrome
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ordu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suleyman Kutalmış Buyuk

Associate Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suleyman Kutalmış Buyuk, PhD

Role: STUDY_CHAIR

Ordu University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ordu University

Ordu, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Suleyman Kutalmış Buyuk, PhD

Role: CONTACT

+904522121286 ext. 7216

Huseyin Simsek, PhD

Role: CONTACT

+904522121286 ext. 7165

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Suleyman Kutalmış Buyuk, PhD

Role: primary

+904522121286 ext. 7216

Huseyin Simsek, PhD

Role: backup

+904522121286 ext. 7165

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-47

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myofunctional Therapy Twin Block
NCT05227469 UNKNOWN NA