Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis

NCT04082949 | Completed Early Phase 1

• 1 other identifier: 2018/45
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Periodontitis; Periodontal Pocket; Periodontal Attachment Loss; Periodontal Diseases

Keywords

Chronic Periodontitis; Autologous fibrin tissue adhesive; Blood Platelets; Non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (2)

• change of pocket depths (PD) in millimeters at different time points

  Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for PD.

  Pocket depths were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months

• change of clinical attachment levels (CAL) in millimeters at different time points

  Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for CAL.

  clinical attachment levels were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months

Secondary Outcomes (3)

• change of bleeding on probing(BOP) scores in % at different time points

  bleeding on probing scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months

• change of gingival index(GI) scores in levels at different time points

  gingival index scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months

• change of plaque index(PI) scores in levels at different time points

  plaque index scores were evaluated in all patients bt baseline and after SRP at the 1st, 3rd, and 6th months

Study Arms (4)

Subgroups:control and initial pocket depths:5-6mm

PLACEBO COMPARATOR

Control group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm

Other: placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis

Subgroups:control and initial pocket depths≥7mm

PLACEBO COMPARATOR

Control group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm

Other: placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis

Subgroups:AFG and initial pocket depths:5-6mm

EXPERIMENTAL

AFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm

Biological: autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis

Subgroups:AFG and initial pocket depths≥7mm

EXPERIMENTAL

AFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm

Biological: autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis

Interventions

autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis BIOLOGICAL

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.

Subgroups:AFG and initial pocket depths:5-6mm; Subgroups:AFG and initial pocket depths≥7mm

placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis OTHER

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.

Subgroups:control and initial pocket depths:5-6mm; Subgroups:control and initial pocket depths≥7mm

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being diagnosed with moderate/severe chronic periodontitis;
• Being older than 18 years;
• Presence of at least three teeth in each quadrant with ≥5 mm probing pocket; depth and ≥3 mm clinical attachment loss;
• Being systemically healthy;
• Not smoking cigarettes.

You may not qualify if:

• Presence of a systemic disease (diabetes, hypertension, coagulopathy, radiotherapy, chemotherapy, etc.);
• Use of any drugs that could influence the results of the study;
• Periodontal treatment in the last six months before the study, or use of antibiotics in the last six months;
• Smoking or alcohol consumption;
• Pregnancy.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Faculty of Dentistry, Department of Periodontology, İnonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (5)

• Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.

  PMID: 12787211 BACKGROUND

• The potential role of growth and differentiation factors in periodontal regeneration. J Periodontol. 1996 May;67(5):545-53.

  PMID: 8724716 BACKGROUND

• Abdul Ameer LA, Raheem ZJ, Abdulrazaq SS, Ali BG, Nasser MM, Khairi AWA. The anti-inflammatory effect of the platelet-rich plasma in the periodontal pocket. Eur J Dent. 2018 Oct-Dec;12(4):528-531. doi: 10.4103/ejd.ejd_49_18.

  PMID: 30369798 BACKGROUND

• Kao RT, Murakami S, Beirne OR. The use of biologic mediators and tissue engineering in dentistry. Periodontol 2000. 2009;50:127-53. doi: 10.1111/j.1600-0757.2008.00287.x. No abstract available.

  PMID: 19388957 BACKGROUND

• Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.

  PMID: 16332231 BACKGROUND

Related Links

• 20\. Sohn D Lecture titled with sinus and ridge augmentation with CGF and AFG. In: Symposium on CGF and AFG. Tokyo, 2010.
• 21\. Sohn D-S, Huang B, Kim J, Park WE,Park CC (2015) Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix (Sticky bone) and CGF-enriched fibrin membrane in Implant Dentistry. Jr Implant Adv Cli Dent 7:11-29.

MeSH Terms

Conditions

Chronic Periodontitis; Periodontal Pocket; Periodontal Attachment Loss; Periodontal Diseases

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Atrophy

Study Officials

• MUSTAFA Ö USLU, Asst. Prof.

  Dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All subgingival procedures were performed by the same periodontology expert, who was blinded to the placebo or AFG application.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Faculty of Dentistry, Department of Periodontology

Model Details: Randomised paralleled clinical trial

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 10, 2019
• Study Start: May 1, 2018
• Primary Completion: December 10, 2018
• Study Completion: May 15, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)