Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (RCT)

University of Baghdad

Status: Enrolling

Conditions: Tooth Movement Techniques; Distalization by Miniscrews

Treatments: Device: Group 2 3D printed; Device: Group 1 conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT07191158

1020425

Details and patient eligibility

About

A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding.

Full description

It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional miniscrew-supported distal jet appliance will be used while for group two, new 3D printed miniscrew-supported molar distalizers is going to be utilized. Lateral cephalometric x-ray and digital models of upper arch will be taken before starting the treatment (T0) and at the end of molar distalization (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.

Enrollment: 28 estimated patients

Sex: All

Ages: 16 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Class II molar relationships bilaterally, with fully erupted 2nd molar.

2. No or minor crowding on the mandible to [reserve Class I posterior occlusion after treatment.

3. Good oral health free from caries and periodontal problems at the start of treatment.

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Exclusion criteria

1. Previous history of orthopedic and/or orthodontic treatment.
2. Patients with cleft lip and palate and/or craniofacial syndrome
3. Patients with bad oral habit.
4. Active periodontal disease.
5. Sever rotation of maxillary molars. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Group 1 distalization

Active Comparator group

Description:

Conventional miniscrew-supported distal jet appliance

Treatment:

Device: Group 1 conventional

Group 2 (interventional)

Experimental group

Description:

New 3D printed miniscrew-supported molar distalizers

Treatment:

Device: Group 2 3D printed