Periodontal Diseases Clinical Trial
Official title:
Evaluation of Clinical Effects of Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
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.
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.
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