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NCT Number: NCT07525531

Effects of PRF and i-PRF on Clinical and Biochemical Parameters in Non-Surgical Periodontal Therapy

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Atakum, 55200, Turkey (Türkiye)

About this study

his study was designed as a randomized controlled clinical trial to evaluate the adjunctive effects of platelet-rich fibrin (PRF) and injectable platelet-rich fibrin (i-PRF) in individuals with periodontitis undergoing non-surgical periodontal therapy (NSPT).

A total of 56 participants were included in the study, comprising 42 systemically healthy patients diagnosed with periodontitis and 14 systemically and periodontally healthy individuals serving as controls. Periodontitis patients were randomly allocated into three treatment groups using a sealed-envelope method: NSPT alone (scaling and root planing, SRP), NSPT with adjunctive PRF application, and NSPT with adjunctive i-PRF application.

PRF and i-PRF were prepared from autologous venous blood obtained from the participants and were applied locally into periodontal pockets immediately following SRP.

Clinical periodontal parameters were recorded at baseline and at the 2nd, 4th, and 6th weeks following treatment. Gingival crevicular fluid (GCF) samples were collected at baseline and at the 2nd and 6th weeks. The levels of inflammatory cytokines (IL-1β, TNF-α, IL-6) and bone metabolism-related biomarkers (OPG and RANKL) in GCF were quantified using enzyme-linked immunosorbent assay (ELISA).

The findings of this study provided insight into the potential clinical and biochemical benefits of PRF and i-PRF as adjunctive approaches in NSPT and allowed comparison with periodontally healthy conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Non-surgical periodontal therapy (NSPT)

Procedure

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.

Platelet-rich fibrin (PRF)

Biological

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.

Injectable Platelet-Rich Fibrin (i-PRF)

Biological

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.

Primary outcomes

  1. Change in probing depth (PD)

    Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks

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

Secondary outcomes

  1. Change in clinical attachment level (CAL)

    Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks

    Change in clinical attachment level (CAL) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline and follow-up measurements.

  2. Change in plaque index (PI)

    Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks

    Change in plaque index (PI) scores assessed at baseline and during follow-up visits.

  3. Change in gingival index (GI)

    Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks

    Change in gingival index (GI) scores evaluated at baseline and follow-up visits.

  4. Change in bleeding on probing (BoP)

    Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks

    Change in bleeding on probing (BoP) assessed at six sites per tooth at baseline and follow-up visits.

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

    Time frame: Baseline, 2 weeks, and 6 weeks

    Change in IL-1β levels in gingival crevicular fluid measured using ELISA.

  6. Change in gingival crevicular fluid (GCF) TNF-α levels

    Time frame: Baseline, 2 weeks, and 6 weeks

    Change in TNF-α levels in gingival crevicular fluid measured using ELISA.

  7. Change in gingival crevicular fluid (GCF) IL-6 levels

    Time frame: Baseline, 2 weeks, and 6 weeks

    Change in IL-6 levels in gingival crevicular fluid measured using ELISA.

  8. Change in gingival crevicular fluid (GCF) OPG levels

    Time frame: Baseline, 2 weeks, and 6 weeks

    Change in OPG levels in gingival crevicular fluid measured using ELISA.

  9. Change in gingival crevicular fluid (GCF) RANKL levels

    Time frame: Baseline, 2 weeks, and 6 weeks

    Change in RANKL levels in gingival crevicular fluid measured using ELISA.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

The Effects of Adjunctive PRF and i-PRF Applications on GCF Levels of IL-1ß, TNF-α, IL-6, OPG and RANKL in Non-surgical Periodontal Therapy

Acronym: PRF-NSPT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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