Maxillary Segmental Distalization Using Digitally Printed Appliances

NCT ID: NCT06511219

Last Updated: 2025-05-30

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-12

Study Completion Date

2026-04-12

Brief Summary

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Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.

Detailed Description

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Ethical approval All selected patients will be informed about the aims and characteristics of the study, the potential risks and benefits and the option of withdrawing from it whenever they desire. Then all patients will sign the informed consent document. All patients will be informed about the results after finishing. All selected patients' personal data and details will be held and handled confidentially and privately in the orthodontic department, faculty of dentistry, Mansoura university.

Trial design

Patients will be randomly allocated into two groups as follow:

1. First group: Buccal segmental digitally printed maxillary distalizer (infrazygomatic mini-implant IZC).
2. Second group: palatal segmental digitally printed maxillary distalizer.

The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews.

The distalizer will be composed of digitally printed metal shell which is bonded to the palatal surface of the whole posterior segment.

Transpalatal arm will connect the two sides to avoid buccal tipping during distalization.

The distalization will be done by placing chain elastics from the miniscrews to the hook present in the mesial aspect of the appliance.

The palatal segmental distalizer will take anchorage from miniscrews placed in the anterior palate.

The appliance will be bonded to the palatal surface of the posterior segment and containing two anterior and two posterior hooks.

The distalization will be performed by using chain elastics between the anterior and posterior hooks.

Force: 300-350 gram per side which will be measured using force gauge.

A follow-up session will be scheduled every 3weeks, and the appliance will be removed in both groups after the patient reach a Class I relationship. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization.

Conditions

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Class II Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews (IZC).

the palatal distalizer take anchorage from palate
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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maxillary segmental distalization using infrazygomatic digitally printed appliances

maxillary segmental distalization using infrazygomatic digitally printed appliances

Group Type ACTIVE_COMPARATOR

maxillary segmental distalization

Intervention Type DEVICE

maxillary segmental distalization using skeletal anchored digitally printed appliances

maxillary segmental distalization using palatal digitally printed appliances

maxillary segmental distalization using palatal digitally printed appliances

Group Type ACTIVE_COMPARATOR

maxillary segmental distalization

Intervention Type DEVICE

maxillary segmental distalization using skeletal anchored digitally printed appliances

Interventions

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maxillary segmental distalization

maxillary segmental distalization using skeletal anchored digitally printed appliances

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients age (13- 18) years.
* Full permanent dentition except third molar.
* Class II malocclusion with at least an end-on Class II molar relationship bilaterally.
* normal or short lower facial height.

Exclusion Criteria

* Systemic conditions that may interfere with the treatment.
* Bad habits that might jeopardize the appliance.
* Transverse discrepancy.
* Previous orthodontic treatment.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Elabd

teaching assistant - orthodontic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dentistry

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Asmaa A Elabd, teatching assistant

Role: CONTACT

01068836018

Marwa A Tawfik, professor

Role: CONTACT

Facility Contacts

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mansoura university

Role: primary

Other Identifiers

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phd

Identifier Type: -

Identifier Source: org_study_id

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