- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06975358
- Original Trial
Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection
June 25, 2025 updated by: Safa Basiouny Alawy
Impact of Alveolar Decortication Combined With CGF Injection on Acceleration of Maxillary Canine Retraction-A Randomized Clinical Trial
The aim of the present study is to evaluate alveolar bone decortication combined with CGF Injection on tooth movement acceleration
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Safa B Alawy, PhD
- Phone Number: 0201009088252
- Email: safa_basyouny@dent.tanta.edu.eg
Study Locations
-
-
-
Tanta, Egypt, 6624033
- Recruiting
- Tanta university
-
Contact:
- Safa B Alawy, PhD
- Phone Number: +201009088252
- Email: safa_basyouny@dent.tanta.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Medically compromised patients.
- Severe crowding in the maxillary arch.
- Chronic intake of NSAIDs or any medication that interfere with OTM.
- Previous orthodontic treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alveolar decortication plus CGF
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
|
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.
|
|
Active Comparator: Control
the other side of the maxillary arch will receive the usual orthodontic treatment without any additional intervention
|
in the control side, the maxillary canine will be retracted without any acceleration procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of canine retraction
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2025
Primary Completion (Estimated)
October 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
May 8, 2025
First Submitted That Met QC Criteria
May 8, 2025
First Posted (Actual)
May 16, 2025
Study Record Updates
Last Update Posted (Actual)
June 27, 2025
Last Update Submitted That Met QC Criteria
June 25, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- #R-OS-12-24-3158
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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