Clinical trial NCT04178590: Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Official title: Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: periodontitis
therapy
Platelet
Rich
Fibrin
Nonsurgical
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: split mouth design
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Periodontal Pocket Depth-PPD
timeFrame: baseline measure (before the intervention)
measure: Periodontal Pocket Depth-PPD - 1m
timeFrame: after 1 month
measure: Periodontal Pocket Depth-PPD - 3m
timeFrame: after 3 months
measure: Periodontal Pocket Depth-PPD - 6
timeFrame: after 6 months
measure: Level of Gingival Margin-LGM
timeFrame: baseline measure (before the intervention)
measure: Level of Gingival Margin-LGM - 1m
timeFrame: after 1 month
measure: Level of Gingival Margin-LGM - 3m
timeFrame: after 3 months
measure: Level of Gingival Margin-LGM - 6m
timeFrame: after 6 months
measure: Clinical Attachment Level- CAL
timeFrame: baseline measure (before the intervention)
measure: Clinical Attachment Level- CAL - 1m
timeFrame: after 1 month
measure: Clinical Attachment Level- CAL - 3m
timeFrame: after 3 months
measure: Clinical Attachment Level- CAL - 6m
timeFrame: after 6 months
measure: Bleeding on Probing-BOP
timeFrame: baseline measure (before the intervention)
measure: Bleeding on Probing-BOP - 1m
timeFrame: after 1 month
measure: Bleeding on Probing-BOP 3m
timeFrame: after 3 months
measure: Bleeding on Probing-BOP - 6m
timeFrame: after 6 months
measure: Plaque Index- PI
timeFrame: baseline measure (before the intervention)
measure: Plaque Index- PI -1m
timeFrame: after 1 month
measure: Plaque Index- PI -3m
timeFrame: after 3 months
measure: Plaque Index- PI - 6m
timeFrame: after 6 months
measure: Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF)
timeFrame: baseline measure (before the intervention)
measure: Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m
timeFrame: after 1 month
measure: Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m
timeFrame: after 3 months
measure: Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m
timeFrame: after 6 months
measure: Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF)
timeFrame: baseline measure (before the intervention)
measure: Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m
timeFrame: after 1 month
measure: Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m
timeFrame: after 3 months
measure: Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m
timeFrame: after 6 months
measure: Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF)
timeFrame: baseline measure (before the intervention)
measure: Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m
timeFrame: after 1 month
measure: Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m
timeFrame: after 3 months
measure: Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m
timeFrame: after 6 months
measure: Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF)
timeFrame: baseline measure (before the intervention)
measure: Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m
timeFrame: after 1 month
measure: Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m
timeFrame: after 3 months
measure: Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m
timeFrame: after 6 months
measure: Periodontal Pocket Microorganisms
timeFrame: baseline measure (before the intervention)
measure: Periodontal Pocket Microorganisms -1m
timeFrame: after 1 month
measure: Periodontal Pocket Microorganisms - 3m
timeFrame: after 3 months
measure: Periodontal Pocket Microorganisms - 6m
timeFrame: after 6 months
measure: Tumor Necrosis Factor Alpha-TNF-α
timeFrame: baseline measure (before the intervention)
measure: Tumor Necrosis Factor Alpha-TNF-α -1m
timeFrame: after 1 month
measure: Tumor Necrosis Factor Alpha-TNF-α - 3m
timeFrame: after 3 months
measure: Tumor Necrosis Factor Alpha-TNF-α -6m
timeFrame: after 6 months
measure: Matrix Metalloproteinase 8 - MMP-8
timeFrame: baseline measure (before the intervention)
measure: Matrix Metalloproteinase 8 - MMP-8 -1m
timeFrame: after 1 month
measure: Matrix Metalloproteinase 8 - MMP-8 - 3m
timeFrame: after 3 months
measure: Matrix Metalloproteinase 8 - MMP-8 - 6m
timeFrame: after 6 months
measure: Alkaline Phosphatase - ALP
timeFrame: baseline measure (before the intervention)
measure: Alkaline Phosphatase - ALP -1m
timeFrame: after 1 month
measure: Alkaline Phosphatase - ALP -3m
timeFrame: after 3 months
measure: Alkaline Phosphatase - ALP -6m
timeFrame: after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Study officials:
affiliation: Assistant Lecturer
name: Mila Vuckovic, Dr.
role: PRINCIPAL_INVESTIGATOR
References: