PRF and Bone Graft in Endodontic Surgeries
Condition: Periapical; Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      AIM: The aim of this study was to compare and evaluate the radiographic healing in patients
      undergoing apical surgery, using Freeze dried mineralized bone allograft and Platelet-rich
      Fibrin. OBJECTIVES: To evaluate radiographic healing after periapical surgery using Freeze
      dried mineralized bone allograft. To evaluate radiographic healing after periapical surgery
      using Platelet rich Fibrin. To compare the radiographic healing after periapical surgery
      using Freeze dried mineralized bone allograft and Platelet rich Fibrin. Method: Patients were
      selected(according to the inclusion criteria) and randomly allocated to PRF and Bone Graft
      groups.Following apicoectomy PRF gel and FDBA graft were prepared and placed in the osseous
      defect followed by placement of PRF membrane for graft stabilization and flap closure.
      Radiographic follow up was done at 1st, 3rd, 6th and 12th months for evaluation of healing
      using Molven Criteria.
    

Detailed description: 
      The present study will be carried out to compare the post surgical healing of Platelet Rich
      Fibrin (PRF) & Mineralised freeze-dried bone allograft (FDBA) in the Department of
      Conservative Dentistry & Endodontics at Saraswati Dental College, Lucknow. The study will be
      commenced only after due permission and clearance from the Institutional Review Board and
      Ethical Committee.

      Cases will be selected according to the inclusion criteria after obtaining informed consent
      from the parents. Patients will be diagnosed based on clinical signs & symptoms, intraoral &
      radiographic findings. A routine medical history followed by blood investigations will be
      part of the surgical protocol.

      After meeting the above criteria the patients will be randomly assigned to either PRF group
      (Group-A) or Mineralised FDBA group (Group-B) After successful administration of Local
      Anaesthesia the surgical procedure will be carried out that will include reflection of a full
      thickness mucoperiosteal flap by sulcular incision and two relieving vertical incisions.
      Debridement of tissues at the defect site will be done followed by irrigation with sterile
      saline solution.

      In Group-A patients :- 10ml of venous blood will be drawn from the patients by using a 18
      gauge needle after selecting a suitable site for venipuncture. Blood will be collected in
      tubes without anticoagulant and immediately centrifuged at 3,000 rpm for 10min which will
      result in a fibrin clot containing the platelets located in the middle of the tube, between a
      layer of red blood cells at the bottom and acellular plasma at the top. This clot will be
      removed from the tube and the attached red blood cells will be scraped off and discarded.

      PRF will be placed into the defect site and wound closure will be performed using appropriate
      sutures.

      In Group-B patients :- Graft material i.e., Mineralised freeze-dried bone allograft (obtained
      from Tissue Bank, Tata Memorial Hospital) will be mixed with sterile saline solution,
      followed by careful placement into the defect site.

      The flap will be then re-placed to its original position and sutured with appropriate sutures
      to ensure complete soft tissue coverage of the graft site.

      Sutures will be removed after 7 days post-operatively. The cases will be followed up with
      clinical and radiographic examination and will be recalled at intervals of 3,6, and 9 months
      to assess the periapical area.

      *Any changes in the plan of study will be made as in when necessary following which suitable
      statistical analysis will be used to analyse the result.
    

Intervention name(s): Platelet Rich Fibrin; FDBA
Intervention type(s): Biological; Biological
Intervention description(s): regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.; regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment