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

NCT04178590 | Completed Phase 4 Results

• 1 other identifier: UBelgrade 783/2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis

Keywords

periodontitis; therapy; Platelet; Rich; Fibrin; Nonsurgical

Outcome Measures

Primary Outcomes (52)

• 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

Study Arms (2)

SRP + Injectable Platelet-Rich Fibrin

EXPERIMENTAL

Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin

Drug: SRP + Injectable Platelet-Rich Fibrin

SRP + placebo

PLACEBO COMPARATOR

Scaling and root planing in conjunction with saline

Drug: SRP + placebo

Interventions

SRP + Injectable Platelet-Rich Fibrin DRUG

Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing

Also known as: SRP + i-PRF

SRP + Injectable Platelet-Rich Fibrin

SRP + placebo DRUG

Saline application during scaling and root planing

Also known as: SRP + saline

SRP + placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

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

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Periodontitis

Interventions

proliferation regulatory factors, human urine; Sodium Chloride

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr Mila Vuckovic
• Organization: Department of Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade

jovanovic.dr.mila@gmail.com

+381637060694

Study Officials

• Mila Vuckovic, Dr.

  Assistant Lecturer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, DDS, MSc, PhD

Model Details: split mouth design

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: October 2, 2019
• Primary Completion: June 29, 2020
• Study Completion: July 9, 2020
• Last Updated: July 13, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-07

Locations

SE (1)