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NCT04178590: EIPRFITCP

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

Completed Phase 4 Results posted Last updated 13 July 2020
What this trial tests

Phase 4 trial testing SRP + Injectable Platelet-Rich Fibrin in Periodontitis in 32 participants. Completed in 9 July 2020.

Timeline
2 October 2019
Primary endpoint
29 June 2020
9 July 2020

Quick facts

Lead sponsorUniversity of Belgrade
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment32
Start date2 October 2019
Primary completion29 June 2020
Estimated completion9 July 2020
Sites1 location across Serbia

Drugs / interventions tested

Conditions studied

Sponsor

University of Belgrade

Who can join

Adults 20 to 65, any sex, with Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Periodontal Pocket Depth-PPD Primary · baseline measure (before the intervention)

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin3.735± 0.863
SRP + Placebo3.696± 0.851
Periodontal Pocket Depth-PPD - 1m Primary · after 1 month

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin2.398± 0.792
SRP + Placebo2.876± 0.804
Periodontal Pocket Depth-PPD - 3m Primary · after 3 months

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin1.990± 0.640
SRP + Placebo2.567± 0.701
Periodontal Pocket Depth-PPD - 6 Primary · after 6 months

assessment of periodontal pocket depth by probing mean value of one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin1.778± 0.542
SRP + Placebo2.409± 0.640
Level of Gingival Margin-LGM Primary · baseline measure (before the intervention)

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

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin1.737± 0.567
SRP + Placebo1.787± 0.589
Level of Gingival Margin-LGM - 1m Primary · after 1 month

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

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin0.948± 0.573
SRP + Placebo1.150± 0.462
Level of Gingival Margin-LGM - 3m Primary · after 3 months

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

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin0.782± 0.580
SRP + Placebo0.877± 0.533
Level of Gingival Margin-LGM - 6m Primary · after 6 months

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

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin0.808± 0.518
SRP + Placebo0.794± 0.457
Clinical Attachment Level- CAL Primary · baseline measure (before the intervention)

assessment of clinical attachment level- CAL by probing

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin2.009± 0.724
SRP + Placebo2.018± 0.715
Clinical Attachment Level- CAL - 1m Primary · after 1 month

assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin1.453± 0.643
SRP + Placebo1.755± 0.654
Clinical Attachment Level- CAL - 3m Primary · after 3 months

assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin1.237± 0.610
SRP + Placebo1.619± 0.618
Clinical Attachment Level- CAL - 6m Primary · after 6 months

assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

GroupValue95% CI
SRP + Injectable Platelet-Rich Fibrin1.226± 0.580
SRP + Placebo1.585± 0.619

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of SRP + Injectable Platelet-Rich Fibrin

Trials testing the same drug.

Other recruiting trials for Periodontitis

Currently open trials in the same condition.

Other University of Belgrade trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04178590.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing