Comparison Between Two Regenerative Scaffolds
Condition: Pulp Necroses
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional

Summary: 
      This study was performed to compare endodontic regeneration outcome in necrotic mature single
      rooted teeth with periapical radiolucency using platelet rich fibrin (PRF) & concentrated
      growth factor (CGF) as a different natural scaffold by evaluation of:

        -  Regaining pulp sensibility by thermal test (hot and cold)

        -  Periapical healing using digital radiography and selected samples will be evaluated
           using Cone Beam Computed Tomography (CBCT).
    

Detailed description: 
      The current study was designed as randomized controlled clinical trial with an allocation
      ratio 1:1 and conducted in the clinic of Endodontic Department, Faculty of Dental Medicine
      for Girls, Al-Azhar University. The study was designed, analyzed and interpreted according to
      the Consolidated Standards of Reporting Trials (CONSORT 2010) checklist of information.
      Ethical approval for the human research was obtained in accordance with guidelines from
      Research Ethics Committee (REC) of the institute with the code number: P-EN-21-02. All
      patients read and signed an informed consent form with details about the study along with the
      benefits and risks of the therapy (Appendix A).A total of thirty-six patients were examined
      for this study.

      After clinical and radiographic examinations only eighteen patients from cases that were
      fulfilling the inclusion criteria were selected according to sample size calculation.
      Eighteen cases was divided randomly into two groups (9 cases each):

      Group I (PRF group):

      Preparation of PRF:

      Five ml blood was drawn from the patient's right median cubital vein into a test tube without
      the addition of an anticoagulant and centrifuged immediately at 3000 rpm for 10 minutes

      Group II (CGF group):

      Preparation of CGF:

      Ten ml of intravenous blood sample from the patient will be obtained and placed in centrifuge
      tubes without anticoagulants; accelerated for 30 seconds; centrifuged at 2700 rpm for 2 min,
      2400 rpm for 4 min, 2700 rpm for 4 min, and 3000 rpm for 3 min; and decelerated for 36 secs
      to stop.

      Methodology:

      Common treatment protocol will be as follow:

      First visit: tooth was isolated using rubber dam followed by access cavity preparation and
      working length determination. Mechanical preparation of root canal was performed using rotary
      instrumentation then the canal was irrigated by 1.5% NaOCl between each successive file.
      After drying the canal with paper point, Calcium hydroxide as intracanal medicament was
      placed. The access cavity was sealed with a cotton pellet and glass ionomer cement for three
      weeks.

      Second visit: plain anesthesia without a vasoconstrictor was administrated. Glass ionomer was
      removed under the isolation with rubber dam. Calcium hydroxide was flushed from the canal
      using 5ml sterile saline followed by irrigation using 20ml of 17% ethylene diamine tetra
      acetic acid (EDTA) then drying the canal using paper point. Intentional over-instrumentation
      3 mm beyond the apex was done using sterile #35 k file to induce bleeding inside the canal
      followed by placement of PRF and CGF inside the canal in group I and group II respectively
      followed by placement of 3 mm mineral trioxide aggregate (MTA) below cementoenamel junction
      and the coronal cavity will be sealed using composite.

      The regeneration outcome will be evaluated 6 month and 1 year follow up, clinically using
      thermal test to ensure the restoration of pulp sensibility or not and radiographically using
      digital radiograph to assess the periapical healing. Selected samples will be evaluated using
      Cone Beam Computed Tomography (CBCT).
    

Intervention name(s): Endodontic regeneration using concentrated growth factor compared with Platelet rich fibrin
Intervention type(s): Procedure
Intervention description(s): regeneration of mature necrotic teeth with periapical abscess using concentrated growth factor compared with Platelet rich fibrin to allow healing of periapical lesion and regaining sensibility
Other intervention name(s): Endodontic regeneration of mature teeth
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The current study was designed as randomized controlled clinical trial with an allocation ratio 1:1
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: regeneration, mature teeth