NCT06975358

Brief Summary

The aim of the present study is to evaluate alveolar bone decortication combined with CGF Injection on tooth movement acceleration

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 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

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 8, 2025

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of canine retraction

    4 months

Study Arms (2)

Alveolar decortication plus CGF

EXPERIMENTAL

Alveolar decortication followed by submucosal CGF injection (70 units) disto-buccal and disto-palatal to the maxillary canine will be randomly assigned to one side of the maxillary arch (experimental) while the other side serve as (control) receiving orthodontic treatment without any additional intervention

Procedure: Alveolar decortication plus CGF injection

Control

ACTIVE COMPARATOR

the other side of the maxillary arch will receive the usual orthodontic treatment without any additional intervention

Procedure: canine retraction without acceleration

Interventions

Experimental sides will receive CGF injection (70 units) disto-buccal and disto-palatal to the maxillary canine after performing decortication. After administration of local anesthesia, two-line flap will be performed from the mesial surface of the maxillary second premolar to the distal surface of the maxillary canine Mucoperiosteal flap will be reflected in the buccal side. Two millimeters of marginal crestal bone will be held intact and using a high-speed drill and a round carbide bur (1mm diameter) under copious saline irrigation, the cortical wall will be penetrated to reach marrow spaces. Multiple perforations (10 holes for standardization) in the cortical bone will be created. The surgical site will then rinsed, and the flap will be repositioned and sutured.

Alveolar decortication plus CGF

in the control side, the maxillary canine will be retracted without any acceleration procedure

Control

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age of the patients ranged from 16: 22 years old.
  • Malocclusion that requires extraction of the maxillary first premolar and canine retraction (e.g. class I bimaxillary dentoalveolar protrusion and class II div 1 malocclusion).
  • Maximum anchorage needed for the maxillary arch as a part of the orthodontic treatment plan.
  • Good oral hygiene and periodontal condition.

You may not qualify if:

  • Medically compromised patients.
  • Severe crowding in the maxillary arch.
  • Chronic intake of NSAIDs or any medication that interfere with OTM.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Tanta, 6624033, Egypt

RECRUITING

MeSH Terms

Interventions

Acceleration

Intervention Hierarchy (Ancestors)

MotionPhysical Phenomena

Central Study Contacts

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
SPONSOR INVESTIGATOR
PI Title
Lecturer of Orthodontics

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

May 20, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

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