- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239024
Evaluation of Piezocision Versus Injectable Platelet-rich Fibrin During Orthodontic Canine Retraction Orthodontic Canine Retraction: A Comparative Clinical Study
Evaluation of Piezocision Versus Injectable Platelet-rich Fibrin During Orthodontic Canine Retraction: A Comparative Clinical Stud
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Alazhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:. An age ranges from 14-22 years. 2. Crowding or protrusion that require 1st premolars extraction, followed by symmetrical canine retractions.
3. All permanent teeth present, 3rd molars aren't considered. 4. Good oral hygiene. 5. No systemic disease and/or medication that could interfere with orthodontic tooth movement. 6. No previous orthodontic treatment. 7. No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism, or parafunction. 8. No tooth size, shape, or root abnormalities visible on patient's radiographic records.
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Exclusion Criteria:Patients diagnosed to have an indication for non-extraction approach.
2. Poor oral hygiene or periodontally compromised patient.
- 3. Previous orthodontic treatment. 4. Any implanted assistive (e.g., pacemakers, cochlear implants, etc.). 5. Any skeletal dysplasia or craniofacial malformation. 6. Patients with root resorption, impacted canine or dental anomalies. 7. Any systemic diseases or medications that could interfere with orthodontic tooth movement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Iprf experimental side
Injection of platelet rich fibrin
|
Injection of iprf and piezocisin
|
|
No Intervention: iPrf control side
|
|
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Experimental: Piezocisin experimental side
Flapless incision
|
Injection of iprf and piezocisin
|
|
No Intervention: Piezocision control sode
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1250/5544
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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