Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Inflammatory periodontal disease often results in loss of bone around the teeth. Bone defects
      that have a certain size and shape (called intrabony or intraosseous defects) may be improved
      by using a graft material in the bony defect. The purpose of this study is to compare healing
      of periodontal intrabony defects that are treated using demineralized freeze dried bone
      allograft (DFDBA) versus autogenous platelet-rich fibrin.

      The null hypotheses is that there will be no significant differences in bone fill, CAL gain,
      PD reduction or recession at sites treated with PRF compared to sites treated with DFDBA.
    

Detailed description: 
      This entire protocol involves procedures that are standard care. The purpose of the research
      is to evaluate whether there are any differences in results of periodontal surgical treatment
      using PRF in intrabony defects versus using DFDBA in intrabony defects. The DFDBA used in
      this study is an approved product and will be used in an approved manner. The PRF used in
      this study is an autologous product derived from the patient's own blood and is also being
      used in an approved manner during this study.

      The primary outcomes evaluated in this study will include the soft tissue parameter of gain
      in clinical attachment level (CAL) and the hard tissue parameter of bone fill (BF). Secondary
      outcomes evaluated will include the soft tissue parameters of probing depth (PD) reduction
      and change in gingival recession (GR). These parameters will be evaluated over a 6-month
      period following intraoperative application of the material in advanced periodontal defects
      in 44 subjects (22 subjects per group with expected completion of 15 subjects per group). Six
      months after surgery, final post-operative clinical and radiographic measurements will be
      made.

      Each subject will randomly be assigned (1:1) to receive either flap surgery with autologous
      platelet-rich fibrin (PRF) placed into the intrabony defect (test) or flap surgery with
      demineralized freeze-dried bone allograft (DFDBA) placed into the intrabony defect (control).
      Subjects will be randomized by drawing a sealed envelope from a stack of envelopes, each of
      which will contain a slip of paper on which is written PRF or DFDBA. The number of envelopes
      per group will equal the total number of subjects to be enrolled per group. Because
      collection and processing of PRF requires specific equipment, subjects will be randomized
      just prior to the surgical procedure being performed (before delivery of local anesthesia)
      rather than after flap reflection and debridement.

      Each subject will contribute only 1 study site. If a subject has more than one interproximal
      bony defect in the area being treated surgically, only 1 such site will be chosen as the
      study site. The site with the deepest CEJ-BD measurement will be chosen. All other nonstudy
      sites in the surgical area will be treated with the same material as the adjacent study site
      (PRF or DFDBA). Clinical measurements at the time of surgery and at the 6-month follow-up
      will be made by one of two examiners who are masked as to study group. The same clinical
      examiner who makes measurements at the time of surgery will also make measurements at the
      6-month follow-up.

      Patients will be given post-operative antibiotics for 7 days after surgery as part of
      standard care (amoxicillin 500mg three times a day for 7 days; if allergic to amoxicillin,
      patients will receive doxycycline 100mg twice a day for 7 days). Subjects will be seen 10-14
      days after surgery for routine follow-up procedures including removal of sutures and removal
      of visible plaque. Subjects will be followed again for routine postoperative procedures at 1
      month, 2 months, and 4 months after surgery. The final postoperative visit will take place at
      6 months post-surgery and will include final radiographic and clinical assessments of the
      study site. The study is over after this 6-month follow-up visit.

      Routine radiographs will be made as standard care procedures pre-operatively and at the
      6-month follow-up time point. Radiographs will be standardized using Rinn XCP holders with
      customized bite registrations, and a 1mm radiopaque square grid (Fixott-Everett grid) will be
      placed over digital sensor plates to allow ease of linear measurement on the digital
      radiographic images. Radiographic measurements will be made by a masked examiner. Hard tissue
      measurements made from the radiographs at baseline and 6-month follow-up will include CEJ to
      base of bony defect (CEJ-BD).Measurements will be made to the nearest 0.5mm.Bone fill is the
      linear change (in mm) in CEJ-BD measurement between baseline examination and 6-month
      follow-up.

      Soft tissue measurements made at baseline and 6-month follow-up will include probing depth
      (PD = gingival margin to base of soft tissue pocket), clinical attachment level (CAL = CEJ to
      base of soft tissue pocket), and gingival recession (GR = CEJ to gingival margin) at each
      defect site. North Carolina 15mm (UNC-15) periodontal probes will be used and measurements
      will be rounded to the nearest 0.5mm.

      Intraoperatively, the bony defect will be measured from CEJ-BD to the nearest 0.5mm. This
      measurement will be made from both the facial and lingual aspect of the interproximal defect
      (i.e., the depth of the interproximal bony defect will be measured from both the facial and
      lingual aspect to its deepest depth). In addition, the number of bony walls will be
      characterized into one of 7 categories: 1) 1-wall, 2) 2-wall, 3) 3-wall, 4) combination
      1,2-wall defect, 5) combination 1,3-wall defect, 6) combination 2,3-wall, or 7)
      circumferential defects. At 6-month follow-up, clinical evaluation of bone fill will be made
      using transgingival probing in the periodontal pocket from the CEJ to the bony crest. This
      measurement will also be made from both the facial and lingual aspect of the interproximal
      defect. This standard care procedure is done using topical anesthetic. Surgical re-entry will
      not be performed.

      For final analysis, the defect will be characterized at the location having the deepest
      CEJ-BD measurement at the time of surgery. For example, if treating a defect on the distal
      aspect of tooth #19 in which the CEJ-BD measurement is 8.5mm from the facial aspect and 7.5mm
      from the lingual at the time of surgery, changes in soft tissue parameters (CAL, PD,
      recession) and hard tissue parameters (bone fill) for that defect will be determined using
      PD, CAL, recession and bone fill measurements taken from the facial aspect only (rather than
      using the mean of facial and lingual measurements to characterize the defect).
    

Intervention name(s): DFDBA; autologous platelet rich fibrin
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontal disease; periodontitis