The Effect of Multiple Injections of (PRF) on The Rate of Canine Retraction

March 9, 2023 updated by: Mohamed Mamdouh Mohamed Elmoghazy Alkhawaga, Cairo University

The Effect of Multiple Injections of Platelets Rich Fibrin (i-PRF) on The Rate of Canine Retraction A Split-mouth: A Randomized Controlled Trial

this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Platelet-rich fibrin injection is a second-generation platelet concentrate, prepared from centrifuged blood which is a rich source of platelets, stem cells, and growth factors seven times greater than that released by platelet-rich plasma. It is a simplified procedure with no biochemical manipulation of blood, free from anticoagulants which are known to inhibit wound healing or any gelling agent, and easily usable with a low rate of mistakes during the preparation procedure.

A variety of growth factors are released by PRF such as platelet-derived growth factor (PDGF), transforming growth factor β (TGF-β), and vascular endothelial growth factor (VEGF), which play a crucial role in angiogenesis, collagen synthesis, and bone regeneration.

Treatment with extraction especially in adult patients may take a longer time due to reported increase in bone density and lower bone regenerative rate. Also, the retraction process to close extraction spaces most of the time is accompanied by bone loss and root resorption as reported in the previous studies. i-PRF can accelerate tooth movement, in addition, prevent tooth retraction undesirable side effects.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 3

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

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt
        • Recruiting
        • Vice president of graduate studies of Cairo University
        • Contact:

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

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patient
  • Full set of permanent dentition (excluding third molars).
  • Good oral hygiene
  • protrusion cases that require extraction of premolars (Bimaxillary protrusion or class II div 1)

Exclusion Criteria:

  • History of previous orthodontic treatment.
  • Systemic disease or drugs affecting tooth movement.
  • Smokers
  • Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases)
  • Severe crowding cases with ectopic erupted canines

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: injection site
it is the arm where the patients will receive the PRF injection intraligamentally in distobuccal, and distopalatal areas of the distal surface of the canine also submucosal injection will be given buccally and palatially (0.25mm) for each side in either the right or left side of the arch.
Procedure: Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement

Preparatory phase

  • Space closure will be done on a 17x25 stainless steel wire
  • Both molars will be indirectly anchored to the miniscrew
  • Extend closing coil spring of suitable length from the canine hock to the first molar hock for retraction.
  • Apply a force of 150gm for each side. The force is measured by a force gauge and activated each visit to keep it constant all over the retraction phase. PRF Injection protocol
  • The First injection will be 3 weeks before extraction
  • By the end of the fourth week the patients will be referred for pre-intervention records. Upper arch CBCT will be obtained to take preintervention measurements of the alveolar bone.
  • At the time of canine retraction patient will receive another injection immediately and an alginate impression will be taken
  • follow up every month and injection will be repeated month after month with an observational period of 5 months.
Other Names:
  • The effect of autologous platelet concentrates on orthodontic tooth movement
No Intervention: control site
it is the arm where the patients will not receive any injection with the same method of retraction as the intervention side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of canine retraction.
Time Frame: 5 months
Rate of orthodontic tooth movement will be measured by calculating the difference in the canine position in mm throughout digital superimposition of consecutive digital models that will be made every four weeks.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Assess bone level between intervention and control side.
Time Frame: bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)
1. bone level between intervention and control side will be assessed through pre and post retraction CBCT for the upper arch.
bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Periodontal health at the injection side.
Time Frame: 5 months
2. Assess Periodontal health on the injection side through periodontal charting mainly propping depth.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed M Alkhawaga, BDS, Cairo University
  • Study Director: Fady Fahim, phD, Cairo University
  • Study Chair: Sally Magdy, phD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I-PRF in orthodontics

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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