Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects
Condition: Periodontal Attachment Loss; Periodontal Bone Loss; Periodontal Diseases
MeSH terms: Alveolar Bone Loss; Periodontal Diseases; Periodontal Attachment Loss
Study type: Interventional

Summary: 
      The primary outcome of periodontal reconstructive therapy is to regenerate all tissues of the
      periodontium including a functional periodontal ligament, alveolar bone and cementum. A
      number of treatment modalities including the use of bone grafts, guided tissue regeneration
      (GTR), and the addition of biological agents have been used with large heterogeneity in the
      clinical and histological outcomes. The rationale of using a filling material when treating
      unfavorable and large intrabony defects (IBDs) with membranes or biological agents consists
      of sustaining the overlying soft tissues in the presence of a non-contained defect's
      architecture, at the same time enhancing the stability of coagulum; and facilitating the
      proliferation of mesenchymal progenitor cells. Among bone grafts available, anorganic bone
      bone (ABB) have been widely used in periodontics for the treatment of IBDs In recent years,
      the increasing understanding of the role of growth factors (GFs) in the wound healing process
      suggested the use of these biological agents in the regenerative treatment of periodontal
      bony defects. Noninferiority trials are designed to demonstrate that the effect of a new
      treatment is adequately similar to an active control by more than a specified margin The aim
      of this study is to verify if the combined use of PRF (Platelet Rich Fibrin) and ABB in the
      management of IBDs may be a treatment modality that is clinically "not inferior" compared to
      the membrane + ABB one, since the combined periodontal regenerative technique has been
      already tested in literature as a "gold standard" periodontal regenerative technique.
    

Detailed description: 
      Experimental Design This is a prospective, randomized and controlled clinical trial designed
      to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities
      of IBDs: test sites ( TS) will be treated by a combination of PRF and ABB; control sites (CS)
      will receive the combined treatment of collagen membrane + ABB. The patients enrolled will
      exhibit unfavorable IBDs and all experimental sites will be accessed with a simplified
      papilla preservation flap (SPPF) procedure. The filling material (ABB) will be common to both
      treatments: therefore, the investigation focused on the addictive effect of PRF used instead
      of COLLAGEN MEMBRANE. Collagen membrane is chosen as the active control (AC) as it is
      currently considered as the "gold standard" among the biological agents for the treatment of
      IBDs.

      A non-inferiority trial (NIT) is designed to verify whether to use PRF instead of collagen
      membrane in association with ABB can lead to not inferior therapeutic results, reducing the
      treatment's cost and allowing the clinicians to use autogenous materials only.

      Study Population 62 patients (33 males and 29 females) aged 42 to 64 years (mean: 53±12)
      seeking treatment at the Unit of Periodontology of the "G. D'Annunzio" University of Chieti-
      Pescara, Italy, and affected by moderate-to-severe chronic periodontitis, will be selected
      for the study. The inclusion criteria are: 1) no systemic diseases; 2) no medications
      affecting periodontal status during the previous 6 months; 3) not pregnant or lactating; 4)
      non-smoker; and 5) the following dental and periodontal factors: a full-mouth plaque score
      (FMPS)25 and a full-mouth bleeding score (FMBS)26 < 20% at the time of surgery, no
      periodontal therapy in the 2 previous years, no inadequate endodontic treatment at the
      experimental sites, no dental mobility, ≥ 20 teeth, exhibit vertical bone loss detected by
      radiographic examination ( ACL (alveolar crest level) - (BD bottom of the defect) distance =
      BDD (Bone defect depth ) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12
      weeks after non- surgical therapy [ scaling and root planing ( SRP)]. Only predominantly 1-,
      combined 1- and 2-, 2-walls defects or teeth with a defect angle ≥ 36° were considered in
      this study (unfavorable IBDs). To be included in this category, the IBDs should not have a
      3-wall component >20% of the total defect depth. The architecture of the defect had to be
      confirmed by observation during the surgical intervention. Each patient will participate in
      the study with a single experimental site. In the case that a patient will have more than one
      IBD with clinical features that could be eligible for study, the most severe defect will be
      chosen. The participants volunteered for the study after they will receive verbal and written
      information and signed a consent form approved by the Ethical Committee of the G. D'Annunzio
      University of Chieti - medical faculty. The study protocol is in accordance with the
      Declaration of Helsinki of 1975, revised in Tokyo in 2004. The study was performed from
      February 2013 to December 2016. Four months before the surgical treatment, all 44 patients
      will undergo SRP by ultrasonic instruments II and hand curettes¶ and motivational
      instructions on oral home care.
    

Intervention name(s): Periodontal Surgery with PRF+ABB; Periodontal Surgery with Collagen Membrane +ABB
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be treated by periodontal surgical flaps with the addition of PRF+ Anorganic Bovine Bone filling material; Patients will be treated by periodontal surgical flaps with the addition of Collagen Membrane + Anorganic Bovine Bone filling material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Platelet rich fibrin; bone graft; non inferiority trial