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

Primary Purpose

Chronic Periodontitis, Periodontal Pocket, Periodontal Attachment Loss

Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
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
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, Autologous fibrin tissue adhesive, Blood Platelets, Non-surgical periodontal therapy

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Dentistry, Department of Periodontology, İnonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

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

Subgroups:control and initial pocket depths≥7mm

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

Subgroups:AFG and initial pocket depths≥7mm

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

change of bleeding on probing(BOP) scores in % 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 BOP.
change of gingival index(GI) scores in levels 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 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for GI
change of plaque index(PI) scores in levels 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 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for PI.

Full Information

First Posted
September 4, 2019
Last Updated
September 5, 2019
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04082949
Brief Title
Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
Official Title
Evaluation of Clinical Effects of Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Diseases
Keywords
Chronic Periodontitis, Autologous fibrin tissue adhesive, Blood Platelets, Non-surgical periodontal therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomised paralleled clinical trial
Masking
Investigator
Masking Description
All subgingival procedures were performed by the same periodontology expert, who was blinded to the placebo or AFG application.
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subgroups:control and initial pocket depths:5-6mm
Arm Type
Placebo Comparator
Arm Description
Control group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm
Arm Title
Subgroups:control and initial pocket depths≥7mm
Arm Type
Placebo Comparator
Arm Description
Control group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm
Arm Title
Subgroups:AFG and initial pocket depths:5-6mm
Arm Type
Experimental
Arm Description
AFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm
Arm Title
Subgroups:AFG and initial pocket depths≥7mm
Arm Type
Experimental
Arm Description
AFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm
Intervention Type
Biological
Intervention Name(s)
autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of pocket depths (PD) in millimeters at different time points
Description
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.
Time Frame
Pocket depths were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Title
change of clinical attachment levels (CAL) in millimeters at different time points
Description
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.
Time Frame
clinical attachment levels were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Secondary Outcome Measure Information:
Title
change of bleeding on probing(BOP) scores in % at different time points
Description
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 BOP.
Time Frame
bleeding on probing scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Title
change of gingival index(GI) scores in levels at different time points
Description
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 GI
Time Frame
gingival index scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Title
change of plaque index(PI) scores in levels at different time points
Description
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.
Time Frame
plaque index scores were evaluated in all patients bt baseline and after SRP at the 1st, 3rd, and 6th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MUSTAFA Ö USLU, Asst. Prof.
Organizational Affiliation
Dr.
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Department of Periodontology, İnonu University
City
Malatya
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available. The outcomes of the treatment will publish in a journal and doesn't need a patient's data collection
Citations:
PubMed Identifier
12787211
Citation
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.
Results Reference
background
PubMed Identifier
8724716
Citation
The potential role of growth and differentiation factors in periodontal regeneration. J Periodontol. 1996 May;67(5):545-53.
Results Reference
background
PubMed Identifier
30369798
Citation
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.
Results Reference
background
PubMed Identifier
19388957
Citation
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.
Results Reference
background
PubMed Identifier
16332231
Citation
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.
Results Reference
background
Links:
URL
https://www.academia.edu/22262758/Utilization_of_Autologous_Concentrated_Growth_Factors_CGF_Enriched_Bone_Graft_Matrix_Sticky_Bone_and_CGF-Enriched_Fibrin_Membrane_in_Implant_Dentistry
Description
20. Sohn D Lecture titled with sinus and ridge augmentation with CGF and AFG. In: Symposium on CGF and AFG. Tokyo, 2010.
URL
https://www.academia.edu/22262758/Utilization_of_Autologous_Concentrated_Growth_Factors_CGF_Enriched_Bone_Graft_Matrix_Sticky_Bone_and_CGF-Enriched_Fibrin_Membrane_in_Implant_Dentistry
Description
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.

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

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