Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04082949
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2019-09-04
Brief Title:
Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
Official Title:
Evaluation of Clinical Effects of Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 moderatesevere 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 patients mouth was administered AFG following SRP test group while the other side of the same patients 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
Two random split-mouth groups were formed among the patients One side of each patients mouth was administered AFG following SRP test group while the other side of the same patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None