Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis

Periodontitis Clinical Trial

— EIPRFITCP  

Official title:

Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178590
• Other study ID #: UBelgrade 783/2
• Status: Completed
• Phase: Phase 4
• Start date: October 2, 2019
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2020
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.

Description:

Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.

Thirty patients with chronic periodontitis who had at least two sites with perriodontal pocket depth (PPD) ≥ 4 mm on contralateral side will be involved in the study. Using a split-mouth design, patients will be treated with SRP + I-PRF -(test group) or SRP only-(control group). Gingival crevicular fluid (GCF) and subgingival plaque will be collected with paper points (DentsplyMaillefer, Tulsa, Oklahoma, USA) at baseline and 1, 3 and 6 months after the treatment. The presence and concentrations of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Tannerella forsythia(Tf) will be analyzed by real-time polymerase chain reaction (qPCR). Periodontal parameters, including bleeding on probing (BOP), probing pocket depth (PPD) and the clinical attachment level (CAL), will be recorded on both sides, as well as concentration of TNF-alpha (tumor necrosis factor alpha), ALP(alkaline phosphatase) and MMP-8 (matrix-metalloproteinase-8).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 9, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• A minimum of 6 teeth per quadrant;

• A minimum of 2 teeth in each quadrant with a probing depth (PD) =5 mm;

• Bleeding on probing (BOP) had to be at =40% tooth sites;

• No involvement of furcation;

• Good general health.

Exclusion Criteria:

• Periodontal therapy within last 12 months;

• Having surgical therapy;

• Use of antibiotics over the last 6 months;

• Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis;

• Pregnancy or nursing;

• Current and former smokers.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• SRP + Injectable Platelet-Rich Fibrin
Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing
• SRP + placebo
Saline application during scaling and root planing

Locations

Country	Name	City	State
Serbia	Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal Pocket Depth-PPD	assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw	baseline measure (before the intervention)
Primary	Periodontal Pocket Depth-PPD - 1m	assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw	after 1 month
Primary	Periodontal Pocket Depth-PPD - 3m	assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw	after 3 months
Primary	Periodontal Pocket Depth-PPD - 6	assessment of periodontal pocket depth by probing mean value of one side of the jaw	after 6 months
Primary	Level of Gingival Margin-LGM	assessment of level of gingival margin-LGM by probing, i.e.distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw	baseline measure (before the intervention)
Primary	Level of Gingival Margin-LGM - 1m	assessment of level of gingival margin-LGM by probing, i.e.distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw	after 1 month
Primary	Level of Gingival Margin-LGM - 3m	assessment of level of gingival margin-LGM by probing, i.e. distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw	after 3 months
Primary	Level of Gingival Margin-LGM - 6m	assessment of level of gingival margin-LGM by probing, distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva) after 6 months	after 6 months
Primary	Clinical Attachment Level- CAL	assessment of clinical attachment level- CAL by probing	baseline measure (before the intervention)
Primary	Clinical Attachment Level- CAL - 1m	assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw	after 1 month
Primary	Clinical Attachment Level- CAL - 3m	assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw	after 3 months
Primary	Clinical Attachment Level- CAL - 6m	assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw	after 6 months
Primary	Bleeding on Probing-BOP	assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).	baseline measure (before the intervention)
Primary	Bleeding on Probing-BOP - 1m	assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).	after 1 month
Primary	Bleeding on Probing-BOP 3m	assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).	after 3 months
Primary	Bleeding on Probing-BOP - 6m	assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).	after 6 months
Primary	Plaque Index- PI	visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome	baseline measure (before the intervention)
Primary	Plaque Index- PI -1m	visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome	after 1 month
Primary	Plaque Index- PI -3m	visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome	after 3 months
Primary	Plaque Index- PI - 6m	visual assessment of plaque index-PI and by probing	after 6 months
Primary	Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF)	Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline	baseline measure (before the intervention)
Primary	Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m	Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month	after 1 month
Primary	Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m	Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months	after 3 months
Primary	Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m	Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months	after 6 months
Primary	Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF)	Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) at baseline	baseline measure (before the intervention)
Primary	Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m	Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month	after 1 month
Primary	Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m	Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months.	after 3 months
Primary	Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m	Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months.	after 6 months
Primary	Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF)	Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) at baseline	baseline measure (before the intervention)
Primary	Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m	Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month.	after 1 month
Primary	Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m	Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months.	after 3 months
Primary	Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m	Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months.	after 6 months
Primary	Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF)	Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) at baseline	baseline measure (before the intervention)
Primary	Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m	Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month.	after 1 month
Primary	Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m	Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months.	after 3 months
Primary	Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m	Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.	after 6 months
Primary	Periodontal Pocket Microorganisms	The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.	baseline measure (before the intervention)
Primary	Periodontal Pocket Microorganisms -1m	The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month.	after 1 month
Primary	Periodontal Pocket Microorganisms - 3m	The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months.	after 3 months
Primary	Periodontal Pocket Microorganisms - 6m	The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months.	after 6 months
Primary	Tumor Necrosis Factor Alpha-TNF-a	concentration of Tumor necrosis factor alpha-TNF-a in GCF using ELISA Kit	baseline measure (before the intervention)
Primary	Tumor Necrosis Factor Alpha-TNF-a -1m	The concentration of Tumor necrosis factor alpha-TNF-a in GCF using ELISA Kit	after 1 month
Primary	Tumor Necrosis Factor Alpha-TNF-a - 3m	The concentration of Tumor necrosis factor alpha-TNF-a using ELISA Kit after 3 months.	after 3 months
Primary	Tumor Necrosis Factor Alpha-TNF-a -6m	The concentration of Tumor necrosis factor alpha-TNF-a using ELISA Kit after 6 months.	after 6 months
Primary	Matrix Metalloproteinase 8 - MMP-8	The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit	baseline measure (before the intervention)
Primary	Matrix Metalloproteinase 8 - MMP-8 -1m	The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.	after 1 month
Primary	Matrix Metalloproteinase 8 - MMP-8 - 3m	The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.	after 3 months
Primary	Matrix Metalloproteinase 8 - MMP-8 - 6m	The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.	after 6 months
Primary	Alkaline Phosphatase - ALP	The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit	baseline measure (before the intervention)
Primary	Alkaline Phosphatase - ALP -1m	The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.	after 1 month
Primary	Alkaline Phosphatase - ALP -3m	The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.	after 3 months
Primary	Alkaline Phosphatase - ALP -6m	The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.	after 6 months