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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: SRP + Injectable Platelet-Rich Fibrin; Drug: SRP + placebo

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRP + Injectable Platelet-Rich Fibrin; Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	Drug: SRP + Injectable Platelet-Rich Fibrin; Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing; Other Names: SRP + i-PRF
Placebo Comparator: SRP + placebo; Scaling and root planing in conjunction with saline	Drug: SRP + placebo; Saline application during scaling and root planing; Other Names: SRP + saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
Periodontal Pocket Depth-PPD - 6	assessment of periodontal pocket depth by probing mean value of one side of the jaw	after 6 months
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)
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
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
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
Clinical Attachment Level- CAL	assessment of clinical attachment level- CAL by probing	baseline measure (before the intervention)
Clinical Attachment Level- CAL - 1m	assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw	after 1 month
Clinical Attachment Level- CAL - 3m	assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw	after 3 months
Clinical Attachment Level- CAL - 6m	assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw	after 6 months
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)
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
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
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
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)
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
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
Plaque Index- PI - 6m	visual assessment of plaque index-PI and by probing	after 6 months
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
Periodontal Pocket Microorganisms	The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.	baseline measure (before the intervention)
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
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
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
Tumor Necrosis Factor Alpha-TNF-α	concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit	baseline measure (before the intervention)
Tumor Necrosis Factor Alpha-TNF-α -1m	The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit	after 1 month
Tumor Necrosis Factor Alpha-TNF-α - 3m	The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months.	after 3 months
Tumor Necrosis Factor Alpha-TNF-α -6m	The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.	after 6 months
Matrix Metalloproteinase 8 - MMP-8	The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit	baseline measure (before the intervention)
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
Matrix Metalloproteinase 8 - MMP-8 - 3m	The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.	after 3 months
Matrix Metalloproteinase 8 - MMP-8 - 6m	The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.	after 6 months
Alkaline Phosphatase - ALP	The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit	baseline measure (before the intervention)
Alkaline Phosphatase - ALP -1m	The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.	after 1 month
Alkaline Phosphatase - ALP -3m	The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.	after 3 months
Alkaline Phosphatase - ALP -6m	The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.	after 6 months

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Mila Vuckovic, Dr., Assistant lecturer

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Actual): June 29, 2020
• Study Completion (Actual): July 9, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Fibrin; periodontitis; Platelet; therapy; Nonsurgical; Rich
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UBelgrade 783/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No