Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Movement Techniques Distalization by Miniscrews

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The study will be a single blinded because both the patients and the investigator will be aware of the allocation during treatment, but the cephalograms and digital models will be scored and coded by an independent person, i.e. pre-and post-treatment cephalograms and digital models will be analyzed after replacing the patients' names with codes, and the examiner conducting the measurement analysis will be unaware of the group to which the patient has been allocated.

Study Groups

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Group 1 distalization

Conventional miniscrew-supported distal jet appliance

Group Type ACTIVE_COMPARATOR

Group 1 conventional

Intervention Type DEVICE

Conventional miniscrew-supported distal jet appliance

Group 2 (interventional)

New 3D printed miniscrew-supported molar distalizers

Group Type EXPERIMENTAL

Group 2 3D printed

Intervention Type DEVICE

New 3D printed miniscrew-supported molar distalizers

Interventions

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Group 1 conventional

Conventional miniscrew-supported distal jet appliance

Intervention Type DEVICE

Group 2 3D printed

New 3D printed miniscrew-supported molar distalizers

Intervention Type DEVICE

Eligibility Criteria

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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. -

Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes