NCT06511219

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2026

Completed
Last Updated

May 30, 2025

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

June 21, 2024

Last Update Submit

May 24, 2025

Conditions

Keywords

class II maloccluusion, miniscrew

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (2)

maxillary segmental distalization using infrazygomatic digitally printed appliances

ACTIVE COMPARATOR

maxillary segmental distalization using infrazygomatic digitally printed appliances

Device: maxillary segmental distalization

maxillary segmental distalization using palatal digitally printed appliances

ACTIVE COMPARATOR

maxillary segmental distalization using palatal digitally printed appliances

Device: maxillary segmental distalization

Interventions

maxillary segmental distalization using skeletal anchored digitally printed appliances

maxillary segmental distalization using infrazygomatic digitally printed appliancesmaxillary segmental distalization using palatal digitally printed appliances

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Systemic conditions that may interfere with the treatment.
  • Bad habits that might jeopardize the appliance.
  • Transverse discrepancy.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentistry

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Central Study Contacts

Asmaa A Elabd, teatching assistant

CONTACT

Marwa A Tawfik, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews (IZC). the palatal distalizer take anchorage from palate
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant - orthodontic department

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 19, 2024

Study Start

April 12, 2024

Primary Completion

January 12, 2026

Study Completion

April 12, 2026

Last Updated

May 30, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations