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NCT Number: NCT06511219

Maxillary Segmental Distalization Using Digitally Printed Appliances

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

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry

Al Mansurah, 35516, Egypt

Location status: Recruiting

Location contact

mansoura university

CONTACT

About this study

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:

  • First group: Buccal segmental digitally printed maxillary distalizer (infrazygomatic mini-implant IZC).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

maxillary segmental distalization

Device

maxillary segmental distalization using skeletal anchored digitally printed appliances

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa A Elabd, teatching assistant

CONTACT

[email protected]

01068836018

Marwa A Tawfik, professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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