NCT06823986

Brief Summary

Extraction space consumption and overjet reduction after maxillary anterior enmasse retraction in orthodontics

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

December 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 7, 2025

Last Update Submit

February 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • extraction space consumption and amount of overjet reduction in millimeters.

    Cone beam computed tomography and cast scanning

    2 years

Study Arms (2)

Retraction with mini screw and power arm

EXPERIMENTAL

Ten patients will be treated with mini screw and power arm

Device: Retraction of anterior teeth by putting miniscrews and power arm

Retraction with mini screw and welded hook in main wire arch

EXPERIMENTAL

Ten patients will be treated with mini screw and welded hook in main wire arch

Device: Retraction of upper anterior teeth by putting miniscrews and welded hooks in main wire arch

Interventions

Enmasse retraction of upper anterior teeth after extraction of upper first permanent premolar on miniscrews and power arm

Retraction with mini screw and power arm

Enmasse retraction of upper anterior teeth after extraction of upper first permanent premolars on miniscrews and welded hooks in main wire arch

Retraction with mini screw and welded hook in main wire arch

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Young adult male and female patients (Age range from 18 to 25 years) with maxillary dental protrusion.
  • \. Patients with Angle class I or class II division I malocclusion with maxillary anterior teeth protrusion and proclination. 3. Skeletal class I. 4. Healthy compliant and motivated patient. 5. No missing of any tooth except wisdom teeth. 6. Good oral hygiene.

You may not qualify if:

  • \. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Smoking history. 5. Presence of periodontal diseases. 6. Previous maxillary anterior surgery. 7. Gingival overgrowth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omnia Megahed Hussein Hemeid

Cairo, Helwan, 002, Egypt

Location

Study Officials

  • Samir Abdo Ibrahem, Professor

    Professor of orthodontics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 12, 2025

Study Start

December 15, 2023

Primary Completion

December 15, 2024

Study Completion

April 15, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations