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

NCT ID: NCT04178590

Last Updated: 2020-07-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-02

Study Completion Date

2020-07-09

Brief Summary

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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

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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).

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

split mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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SRP + Injectable Platelet-Rich Fibrin

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

Group Type EXPERIMENTAL

SRP + Injectable Platelet-Rich Fibrin

Intervention Type DRUG

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

SRP + placebo

Scaling and root planing in conjunction with saline

Group Type PLACEBO_COMPARATOR

SRP + placebo

Intervention Type DRUG

Saline application during scaling and root planing

Interventions

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SRP + Injectable Platelet-Rich Fibrin

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

Intervention Type DRUG

SRP + placebo

Saline application during scaling and root planing

Intervention Type DRUG

Other Intervention Names

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SRP + i-PRF SRP + saline

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Natasa Nikolic Jakoba

Associate professor, DDS, MSc, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mila Vuckovic, Dr.

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer

Locations

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

Belgrade, , Serbia

Site Status

Countries

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Serbia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UBelgrade 783/2

Identifier Type: -

Identifier Source: org_study_id

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