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Maxillary Segmental Distalization Using Digitally Printed Appliances

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06511219
Enrollment
40
Registered
2024-07-19
Start date
2024-04-12
Completion date
2026-04-12
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Malocclusion

Keywords

class II maloccluusion, miniscrew

Brief summary

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

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.

Interventions

DEVICEmaxillary segmental distalization

maxillary segmental distalization using skeletal anchored digitally printed appliances

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.10 monthsthis 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

Countries

Egypt

Contacts

Primary ContactAsmaa A Elabd, teatching assistant
asmaaelabd55@gmail.com01068836018
Backup ContactMarwa A Tawfik, professor
marwaali.t.g@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026