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

Study Overview
=================
Brief Summary
-----------------
this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.

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.

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

Conditions
-----------------
Platelet-Rich Fibrin, Acceleration, Orthodontics

Intervention / Treatment
-----------------
* Procedure: Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a split-mouth randomized, controlled single-center superiority trial, with two parallel groups with a 1:1 allocation ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: injection site<br>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<br>* 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.<br>* Other names: The effect of autologous platelet concentrates on orthodontic tooth movement;|
| No Intervention: control site<br>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. | 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. | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injectable platelets rich fibrin