Class II Division 1 MalocclusionNCT04810286
Prefabricated Versus 3D-Printing Myofunctional Appliances
A study testing 3d-Printing Myofunctional Appliance in people with Class II Division 1 Malocclusion, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- 3d-Printing Myofunctional Appliance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Increased overjet >4 mm
- Skeletal Class II relationship (ANB > 4 degree)
- No previous orthodontic treatment
Who cannot join
- -Craniofacial syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ordu University
Ordu, 52200
Suleyman Kutalmış Buyuk, PhD, +904522121286 ext. 7216, skbuyuk@gmail.com
Huseyin Simsek, PhD, +904522121286 ext. 7165, dr.huseyinsimsek@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- 3d-Printing Myofunctional Appliance
- Keywords
- Myofunctional treatment, 3D-Print, Prefabricated myofunctional appliance, Class II division 1 malocclusion, Orthodontics
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d-Printing Myofunctional ApplianceProcedure or surgery
To evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 3D-print myofunctional appliance Receives: Procedure: 3d-Printing Myofunctional Appliance |
| Control Group | Active comparator | Prefabricated myfunctional appliance Receives: Procedure: 3d-Printing Myofunctional Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dentoskeletal changes
Dentoskeletal effects of appliances
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Kutalmış Buyuk, Ordu University
- Investigators
- Suleyman Kutalmış Buyuk, PhD, Study chair, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810286
- Sponsor's protocol ID
- 2021-47
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prefabricated Myofunctional Appliances and 3D-Printing Myofunctional Appliances in Children With Class II Division 1 Malocclusion
- ClinicalTrials.gov ID
- NCT04810286
- Acronym / sponsor ID
- 2021-47
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Myofunctional treatment, 3D-Print, Prefabricated myofunctional appliance, Class II division 1 malocclusion, Orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: 3d-Printing Myofunctional Appliance3D-print myofunctional appliance |
| Control Group | Active comparator | Procedure: 3d-Printing Myofunctional AppliancePrefabricated myfunctional appliance |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Increased overjet >4 mm
- Skeletal Class II relationship (ANB > 4 degree)
- No previous orthodontic treatment
Key exclusion criteria (1 listed)
- -Craniofacial syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3d-Printing Myofunctional ApplianceTo evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Rate of dentoskeletal changes
Time frame: 1 year
Dentoskeletal effects of appliances
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Class II Division 1 Malocclusion
Recruiting
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
CLASS II DIVISION 1 MALOCCLUSION
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Recruiting
EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
CLASS II DIVISION 1 MALOCCLUSION
Not yet recruiting
Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
Class II Malocclusion, Class II Malocclusion, Division 1
Not yet recruiting
The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
CLASS II DIVISION 1 MALOCCLUSION, Class II Malocclusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suleyman Kutalmış Buyuk, PhD study chair
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d-Printing Myofunctional Appliance in people with Class II Division 1 Malocclusion, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suleyman Kutalmış Buyuk, PhD (+904522121286 ext. 7216, skbuyuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dentoskeletal changes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.