NCT07525531

Brief Summary

The goal of this clinical trial is to learn if adding platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (i-PRF), obtained from the participant's own blood, to standard non-surgical periodontal treatment helps improve gum health in individuals with periodontitis. It will also assess how these applications affect inflammation and bone-related markers in the gum fluid. The main questions it aims to answer are :

  • Does the application of PRF or i-PRF improve clinical periodontal healing compared to standard treatment alone?
  • Do these applications influence the levels of inflammatory and bone metabolism-related biomarkers in gingival crevicular fluid? Researchers will compare patients receiving PRF or i-PRF in addition to standard periodontal treatment with those receiving standard treatment alone. In addition, the findings obtained from individuals with periodontal disease will be compared with data from periodontally healthy individuals. Participants will:
  • Receive standard periodontal treatment (scaling and root planing)
  • Receive PRF or i-PRF depending on their assigned group
  • Visit the clinic before treatment and at 2, 4, and 6 weeks after treatment for checkups

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 6, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

PeriodontitisPlatelet Rich FibrinNon-Surgical Periodontal TherapyGingival Crevicular FluidIL-1ßTNF-αIL-6OPGRANKL

Outcome Measures

Primary Outcomes (1)

  • Change in probing depth (PD)

    Change in probing depth (PD) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline values with follow-up measurements.

    Baseline, 2 weeks, 4 weeks, and 6 weeks

Secondary Outcomes (9)

  • Change in clinical attachment level (CAL)

    Baseline, 2 weeks, 4 weeks, and 6 weeks

  • Change in plaque index (PI)

    Baseline, 2 weeks, 4 weeks, and 6 weeks

  • Change in gingival index (GI)

    Baseline, 2 weeks, 4 weeks, and 6 weeks

  • Change in bleeding on probing (BoP)

    Baseline, 2 weeks, 4 weeks, and 6 weeks

  • Change in gingival crevicular fluid (GCF) IL-1β levels

    Baseline, 2 weeks, and 6 weeks

  • +4 more secondary outcomes

Study Arms (4)

Non-surgical periodontal therapy (NSPT)

ACTIVE COMPARATOR

Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). No adjunctive biomaterial was applied.

Procedure: Non-surgical periodontal therapy (NSPT)

NSPT + PRF

EXPERIMENTAL

Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, platelet-rich fibrin (PRF) was applied into periodontal pockets.

Procedure: Non-surgical periodontal therapy (NSPT)Biological: Platelet-rich fibrin (PRF)

NSPT + i-PRF

EXPERIMENTAL

Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, injectable platelet-rich fibrin (i-PRF) was applied into periodontal pockets.

Procedure: Non-surgical periodontal therapy (NSPT)Biological: Injectable platelet-rich fibrin (i-PRF)

Healthy control

NO INTERVENTION

Periodontally and systemically healthy participants were included as controls. No periodontal treatment was performed. Gingival crevicular fluid (GCF) samples were collected, and oral hygiene instructions were provided

Interventions

Non-surgical periodontal therapy (NSPT) consisted of full-mouth scaling and root planing (SRP), including the removal of supra- and subgingival deposits using ultrasonic devices and hand instruments.

NSPT + PRFNSPT + i-PRFNon-surgical periodontal therapy (NSPT)

Platelet-rich fibrin (PRF) was prepared from autologous venous blood by centrifugation at 2700 rpm for 12 minutes, processed into a membrane, adapted to the size of the periodontal pocket, and placed into the periodontal pocket using hand instruments.

NSPT + PRF

Injectable platelet-rich fibrin (i-PRF) was prepared from autologous venous blood by low-speed centrifugation at 700 rpm for 3 minutes and injected into periodontal pockets.

NSPT + i-PRF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary consent to participate in the study
  • Individuals aged 18 years or older
  • Systemically healthy individuals
  • Abstaining from the use of any drugs for any purpose
  • No periodontal treatment history in the past six months
  • Individuals who do not smoke

You may not qualify if:

  • Absence of willingness to engage in the studies
  • Individuals under the age of 18
  • Existence of any systemic disease influencing periodontal condition and consistent medication usage
  • Administration of local or systemic antibiotics within the preceding six months
  • Chronicle of periodontal therapy during the past six months
  • History of any periodontal surgical intervention within the past 12 months
  • Pregnancy or lactation in female subjects
  • Teeth with endodontic lesion or mobility degrees 2 and 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator, periodontist

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 20, 2024

Primary Completion

August 5, 2025

Study Completion

December 25, 2025

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations