FenestrationNCT06500559
Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction
A study testing PRP injection and Combined decortication and PRP injection in people with Fenestration and Dehiscence, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Fenestration, Dehiscence
- What is being tested?
- PRP injection and Combined decortication and PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 7 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Medically compromised patients.
- Severe crowding in the maxillary arch.
- Chronic intake of NSAIDs or any medication that interfere with OTM.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fenestration, Dehiscence
- Being tested
- PRP injection, Combined decortication and PRP injection
- Keywords
- accelerated orthodontics, Dehiscence, fenestration, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionProcedure or surgery
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
Combined decortication and PRP injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| group I: PRP injection | Experimental | 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 Receives: Procedure: PRP injection |
| group II: Combined decortication and PRP injection | Experimental | 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 Receives: Procedure: Combined decortication and PRP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar bone dehiscence
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)
Measured: 4 months
Alveolar bone fenestration
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 May 2024
- Primary completion1 Feb 2025
- Study completion7 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FenestrationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Basiouny Alawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500559
- Sponsor's protocol ID
- #R-ORTH-6-24-3117
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alveolar Bone Dehiscence and Fenestration Following Maxillary Canine Retraction Using Two Methods of Tooth Movement Acceleration. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06500559
- Acronym / sponsor ID
- #R-ORTH-6-24-3117
- Conditions
- Fenestration, Dehiscence
- Keywords
- accelerated orthodontics, Dehiscence, fenestration, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I: PRP injection | Experimental | Procedure: PRP injectionAccelerated maxillary canine retraction will be done after PRP injection in one random side of the maxillary arch while the other side serve as control |
| group II: Combined decortication and PRP injection | Experimental | Procedure: Combined decortication and PRP injectionAccelerated 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 |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Medically compromised patients.
- Severe crowding in the maxillary arch.
- Chronic intake of NSAIDs or any medication that interfere with OTM.
- Previous orthodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injectionPRP (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 | Procedure or surgery | group I: PRP injection |
| Combined decortication and PRP injectionExperimental 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. | Procedure or surgery | group II: Combined decortication and PRP injection |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection and Combined decortication and PRP injection in people with Fenestration and Dehiscence, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar bone dehiscence (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.