Maxillary Segmental Distalization Using Digitally Printed Appliances

May 24, 2025 updated by: Asmaa Elabd, Mansoura University

Evaluation of Maxillary Segmental Distalization Using Infra Zygomatic Versus Palatal Digitally Printed Skeletal Anchored Appliances

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Recruiting
        • Dentistry
        • Contact:
          • mansoura university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: maxillary segmental distalization using infrazygomatic digitally printed appliances
Device: maxillary segmental distalization
maxillary segmental distalization using skeletal anchored digitally printed appliances
Active Comparator: maxillary segmental distalization using palatal digitally printed appliances
Device: maxillary segmental distalization
maxillary segmental distalization using skeletal anchored digitally printed appliances

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.
Time Frame: 10 months
this study includes 40 patients with class II molar and canine relation the study aimes to investigate the effect of the skeletal anchored digitally printed distalizers on the distal movement of the maxillary posterior segment in millimeters
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Estimated)

January 12, 2026

Study Completion (Estimated)

April 12, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 24, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • phd

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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