- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06500559
Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction
September 9, 2025 updated by: Safa Basiouny Alawy, Tanta University
Comparison of Alveolar Bone Dehiscence and Fenestration Following Maxillary Canine Retraction Using Two Methods of Tooth Movement Acceleration. A Randomized Clinical Trial
Alveolar bone loss and fenestration are the most prevalent bone defects that often result in root exposure, gingival recession, and potential treatment relapse or failure.
These issues present complications in orthodontic therapy.
Hence, reducing the length of orthodontic therapy and minimizing the occurrence of these serious complications are highly important for orthodontic patients, particularly adults.
platelet-rich plasma (PRP) injection and decortication are two promising methods for accelerated tooth movements.
Thus, The aim of this study is to evaluate alveolar bone dehiscence and fenestrations after canine retraction, using alveolar decortication and PRP injection as two methods for accelerating tooth movements.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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 Locations
-
-
Tanta
-
Tanta, Tanta, Egypt, 6624033
- Tanta University
-
-
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: group I: PRP injection
Accelerated maxillary canine retraction will be done after PRP injection in one random side of the maxillary arch while the other side serve as control
|
PRP (0.7 ml = 70 unit) will be injected submucosal disto-buccal and disto-palatal to the maxillary canine like the local anesthesia injection in group I experimental sides
|
|
Experimental: group II: Combined decortication and PRP injection
Accelerated maxillary canine retraction will be done after combined decortication and PRP injection in one random side of the maxillary arch while the other side serve as control
|
Experimental sides will receive PRP injection 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar bone dehiscence
Time Frame: 4 months
|
Pre- and post- retraction CBCTs will be obtained from patients.
Linear measurement (mm) for dehiscence (LM-D) will be defined as the distance between the alveolar crest to the cementoenamel junction of each root (critical point will be set at 2 mm)
|
4 months
|
|
Alveolar bone fenestration
Time Frame: 4 months
|
Pre- and post- retraction CBCTs will be obtained from patients.
Linear measurement (mm) for fenestration (LM-F) will be recorded when the defect involved only the apical one-third of a root (critical point will be set at 2.2 mm)
|
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 1, 2024
Primary Completion (Actual)
February 1, 2025
Study Completion (Actual)
September 7, 2025
Study Registration Dates
First Submitted
July 8, 2024
First Submitted That Met QC Criteria
July 8, 2024
First Posted (Actual)
July 15, 2024
Study Record Updates
Last Update Posted (Estimated)
September 10, 2025
Last Update Submitted That Met QC Criteria
September 9, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- #R-ORTH-6-24-3117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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