- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616936
Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin
Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin: A Prospective Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt
- Alazhar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:An age range from 15-22 years. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
All permanent teeth present, 3rd molars are excluded. Good oral and general health. No systemic disease/medication that could interfere with orthodontic tooth movement. No previous orthodontic treatment.
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Exclusion Criteria:Patient diagnosed to have an indication for non-extraction approach.
Poor oral hygiene or periodontally compromised patient. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group I
Intervention side: application of i-PRF with distalization of maxillary first molar that will be performed on intervention sides according to a standardized protocol.
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injectable platelet rich fibrin
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No Intervention: Group II
Control side: distalization of maxillary first molar that will be performed without any intervention
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Experimental: Group A
levelling and alignment assisted with Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol.
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injectable platelet rich fibrin
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No Intervention: Group B
leveling and alignment will be commenced without Injection of Injectable platelet-rich fibrin (i-PRF)
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Experimental: Group a
Will includes 9 patients who will receive intrusive arch after leveling and alignment assisted Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol.
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injectable platelet rich fibrin
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No Intervention: Group b
Will includes 9 patients who will receive intrusive utility arches after leveling and alignment without Injection of Injectable platelet-rich fibrin (i-PRF)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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effect of injectable platelet rich fibrin on different tooth movements
Time Frame: post interventional at 4 months
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rate of tooth movement
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post interventional at 4 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
- Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 837/140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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