Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis; Periodontal Pocket; Periodontal Attachment Loss; Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis; Periodontal Pocket; Periodontal Attachment Loss
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Chronic periodontitis is an inflammatory and polymicrobic disease characterized by the
      irreversible loss of alveolar bone and connective tissue attachment of the teeth. Chronic
      periodontitis is the most prevalent type of periodontitis and it is seen in the great
      majority of the adult population.

      The main objective of periodontal treatment is to heal the inflammatory tissue, to eliminate
      unhealthy periodontal pockets, and to reduce the number of pathogenic bacteria. The
      traditional treatment of chronic periodontitis is debridement performed with hand tools and
      ultrasonic devices. However, in deep pockets, which are difficult to access, mechanical root
      surface debridement is not sufficient to remove the biofilm via root instrumentation.

      The regeneration of the periodontium aims at the reconstitution of the periodontal ligament,
      alveolar bone, and cementum. Platelet concentrates have gained popularity in regenerative
      periodontal therapy due to their autologous nature. Their regenerative potential is
      associated with growth factors such as TGFβ-1, PDGF, EGF, IGF-I, and VEGF, stimulate cell
      proliferation and regulate matrix remodeling and angiogenesis. Growth factors are naturally
      occurring proteins that regulate cell growth and development. They also modulate cell
      proliferation, migration, extracellular matrix formation and other cellular functions in
      epithelization. In addition, some growth factors may function as cell differentiation
      factors. These functions of the growth factors support epithelization following surgical
      periodontal treatment and reduce postoperative pain and swelling with their anti-inflammatory
      properties. Furthermore, studies have reported their antibacterial potentials.

      Different platelet concentrates such as platelet-rich plasma (PRP) and platelet-rich fibrin
      (PRF) are obtained when whole blood is centrifuged at different speeds and for different
      durations. When the literature is reviewed, it is seen that these platelet concentrates are
      frequently used in regenerative therapies in dentistry. In 2010, Sohn et al. obtained
      autologous fibrin glue (AFG), an injectable platelet concentrate, by centrifuging venous
      blood for two minutes in a special centrifuge device (Medifuge, Silfradent, Italy; 2400-2700
      rpm). AFG is used, by mixing it with bone grafts, in the production of sticky bone, which
      could be an alternative to titanium mesh and bone block procedures that enable grafts to
      remain more stable in defects.

      It was found in the literature review that studies on AFG, which is a second-generation
      platelet concentrate, are limited in number. It was also found that these studies were
      conducted on sticky bone, obtained by mixing AFG with bone grafts, and there are no studies
      in which AFG is used alone to treat periodontal diseases. The purpose of this study is to
      investigate the effect of AFG, an injectable platelet concentration, on clinical parameters
      in the nonsurgical treatment of chronic periodontitis.
    

Detailed description: 
      This randomized controlled clinical study included patients diagnosed with moderate/severe
      periodontitis who applied to the Department of Periodontology, Faculty of Dentistry, Inonu
      University. Written consent was received from each patient. Approval was obtained from the
      Malatya Clinical Research Ethics Committee for our study, which was designed in compliance
      with the Declaration of Helsinki.

      Two random split-mouth groups were formed among the patients. One side of each patient's
      mouth was administered AFG following SRP (test group), while the other side of the same
      patient's mouth was administered a placebo drug (control group).

      The following periodontal parameters were evaluated in all patients before and after SRP at
      the 1st, 3rd, and 6th months: probing depth (PD), clinical attachment level (CAL), plaque
      index (PI), gingival index (GI), and bleeding on probing (BOP) index. Measurements were
      performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the
      third molars, in 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for PI and GI
      and in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual,
      distolingual) for PD, CAL, and BOP. Clinical attachment level was measured from the
      enamel-cement border. Following the initial measurement, the regions with ≥5 mm pocket depth
      were determined. Measurements were performed only in these regions in the 1st, 3rd, and 6th
      months. The initial pocket depth was considered within two subgroups as regions with 5-6 mm
      pocket depth and regions with ≥7 mm pocket depth.

      Venous blood from each patient (9 mL) was transferred into a tube without any anticoagulant.
      Following the protocol recommended by Sohn et al., the venous blood collected in the tube was
      centrifuged in a special centrifuge machine (Medifuge, Silfradent, Italy). The AFG at the top
      of the tube was collected using an injector.

      Nonsurgical periodontal treatments of the patients were completed in two sessions by a
      periodontology expert.

      In the first session, the supragingival calculus was removed, and patients were given oral
      hygiene training and encouragement. In the second session, the SRP procedure was performed
      under local anesthesia in the regions in which there were periodontal pockets of ≥5 mm in the
      quadrants considered as the control and test groups. The test group was administered AFG
      using a blunt dental injector in the subgingival region, as an adjunct to SRP, while the
      control group was administered the placebo.
    

Intervention name(s): autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis; placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis
Intervention type(s): Biological; Other
Intervention description(s): The purpose of this study was to investigate effects of autologous fibrin glue (AFG) which was an injectable platelet concentration, on clinical parameters in the nonsurgical treatment of chronic periodontitis.Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The test group was administered AFG using a blunt dental injector in the subgingival region, as an adjunct to SRP Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months.; Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The control group was administered placebo as an adjunct to SRP.Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months.
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised paralleled clinical trial
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Chronic Periodontitis; Autologous fibrin tissue adhesive; Blood Platelets; Non-surgical periodontal therapy