NCT06416904

Brief Summary

The study aims to compare the anchorage control using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 13, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

May 12, 2024

Last Update Submit

February 9, 2026

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • Amount of anchorage loss of the maxillary first molars

    After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models

    6 months from the start of the canine retraction and after anterior segment retraction (12 months)

Secondary Outcomes (3)

  • Tipping of the maxillary first molar.

    6 months from the start of the canine retraction and after anterior segment retraction (12 months)

  • Maxillary incisors inclination

    6 months from the start of the canine retraction and after anterior segment retraction (12 months)

  • Maxillary incisors anteroposterior position

    6 months from the start of the canine retraction and after anterior segment retraction (12 months)

Study Arms (2)

arch wire stopper mesial to the maxillary first molar group

EXPERIMENTAL

In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars followed by anterior segment retraction using T-loop on 0.017x0.025 TMA arch wire.

Device: archwire stopper mesial to the maxillary first molar group

maxillary first molar indirectly anchored to the inter-radicular mini-screw group

ACTIVE COMPARATOR

In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw followed by anterior segment retraction using T-loop on 0.017x0.025 TMA arch wire.

Device: inter-radicular mini-screw

Interventions

inter-radicular mini-screwDEVICE

canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.

maxillary first molar indirectly anchored to the inter-radicular mini-screw group
archwire stopper mesial to the maxillary first molar groupDEVICE

canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars.

arch wire stopper mesial to the maxillary first molar group

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients 15-25 years
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Post-pubertal female patients.
  • Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
  • Full permanent dentition (not necessitating third molars).
  • Good oral hygiene.

You may not qualify if:

  • Medically compromised patients.
  • Active periodontal disease or obvious bone loss in the maxillary arch.
  • Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
  • Smoking or any systemic diseases.
  • Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
  • Previous orthodontic treatment.
  • Missing teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

Location

Study Officials

  • Mennatallah Ali

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

May 12, 2024

First Posted

May 16, 2024

Study Start

February 13, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)