Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Enhancing Bone Quality
Condition: Malocclusion, Angle Class II, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent
      retraction of the maxillary canines, will be divided randomly into two groups, and will
      randomly assigned to one side of the maxillary arch at the first premolar region, and the
      other side served as the control. Canine retraction will be initiated after completion of the
      leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force
      per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar
      changes will be assessed immediately before retraction and after 6 months using CBCT.
    

Detailed description: 
      Extraction is a procedure that is currently performed in orthodontics, either in the context
      of early treatment or for adolescents with severe crowding or protrusion/overjet. The
      consequences of this ''simple'' procedure may show up many mucosal and osseous complications
      such as: bone resorption with collapse of the alveolar process, a gingival cleft or gingival
      recession in the area surrounding the extraction site. Besides the potential esthetic
      repercussions, these periodontal defects also give rise to a clinical problem with achieving
      some orthodontic movements, such as complete closure of the space or uprighting a root.

      A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a
      range of width reduction of 2.6-4.6mm, Two-thirds of the loss occurred in the first 3 months,
      the remodeling of alveolar bone in the extraction site always decreases ridge volume and
      deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly.

      Endogenously produced biologicals have been tested based on their roles in the turnover of
      alveolar bone in response to orthodontic tooth movement as well as during wound healing.

      From here it has been thought about using a method to enhance bone quality after extraction.
      The platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate
      wound healing and inducing stem cells differentiation through its growth factors (GFs).

      PRF characteristics in comparison to platelet rich plasma PRP are:

        1. its preparation is completely natural and there is no need for thrombin addition so
           there isn't immune reaction

        2. it contains stem cells

        3. it requires one stage centrifugation

        4. PRF has been reported to gradually release autologous growth factors and expressed
           stronger and more durable effect on the cellular proliferation and differentiation than
           PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic
           treatment, because of its benefits and easiness of using in dental clinic Study sample
           that consists of 20 patients, Allocation of the sides of intervention (PRF injection)
           and control sides is made by computer program (Excel).

      After ensuring of the patients compliance with the terms and conditions of this study, the
      purpose and methods of the study will be explained to the patients using Information Sheet.
      In case of approval to participate, the patients asked to sign the Informed Consent.

      Extra & Intra-oral photographs, impressions and clinical examination will be made.

      Canine retraction will be initiated after completion of the leveling and alignment phase via
      closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of
      patients' blood will be withdrawn and centrifuged (700 rpm within 3 minutes) to get 4ml
      i-PRF. PRF will be injected at the area of the extracted first premolar, The first point
      place is in the buccal interventional side (supra periosteal injection) and the second point
      place is in the palatal interventional side(sub periosteal injection). PRF will be injected
      twice at the beginning and at the middle of the canine retraction.

      High resolution CBCT will be taken before the beginning of canine retraction (T0) and after 6
      months (T1).
    

Intervention name(s): i-PRF; canine retraction
Intervention type(s): Biological; Procedure
Intervention description(s): i-PRF (injectable platelet rich fibrin) assisted upper canine retraction; upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two Arms injectable platelet rich fibrin group: consisted of two subgroups
Experimental group : injectable platelet rich fibrin assisted upper canine retraction
Control group: conventional upper canine retraction
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: i-PRF (injectable platelet rich fibrin); alveolar bone height; canine root resorption; bone density; cone-beam computed tomography