i-PRF & Root Surface Biomodification (iPRF-Perio)

Effectiveness of Injectable Platelet Rich Fibrin Used For Root Surface Biomodification On Clinical Periodontal Parameters

This study is designed to evaluate a new method to improve healing in patients with gum disease (periodontitis). A total of 42 adults with gum pockets deeper than 5 millimeters will take part. All patients will undergo flap surgery, which is a standard treatment for gum disease. Half of the patients will also receive an additional treatment with injectable platelet-rich fibrin (i-PRF), made from their own blood, together with root surface cleaning using EDTA gel. Patients will be followed for 6 months. The study will measure changes in gum pocket depth, gum attachment to teeth, and healing.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Chronic Periodontitis (Disorder)
• Intervention / Treatment: Procedure: Open Flap Debridement (OFD); Other: 24% EDTA Root Conditioning; Biological: Injectable Platelet-Rich Fibrin (i-PRF)

Detailed Description

Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues. Open flap debridement (OFD) is a standard surgical approach for the management of deep periodontal pockets. Injectable platelet-rich fibrin (i-PRF) is an autologous, anticoagulant-free platelet concentrate prepared with low-speed centrifugation and characterized by a fibrin network that gradually releases growth factors. Neutral-pH 24% EDTA root-surface conditioning is used to remove the smear layer and expose collagen, which may support early cell attachment and the adsorption of bioactive molecules.

This single-center, randomized, parallel-group, open-label clinical trial is designed to evaluate whether the adjunctive use of i-PRF after EDTA root conditioning provides additional benefits compared with EDTA conditioning alone. Adults with periodontitis will be enrolled at a university periodontal clinic and randomized to one of two groups:

Control group: OFD with 24% EDTA gel conditioning (3 minutes)

Test group: OFD with 24% EDTA gel conditioning (3 minutes) followed by application of i-PRF retained on defect surfaces for 5 minutes

A mixed defect model (sites with both intrabony and horizontal components) will be included to reflect real-world clinical presentations.

All participants will receive standardized Phase I therapy before surgery. On the day of surgery, an antiseptic rinse will be performed, local anesthesia will be administered, full-thickness flaps will be elevated, and meticulous debridement/root planing will be completed. In the test arm, i-PRF will be prepared from venous blood collected into plain glass tubes and centrifuged at ~700 rpm (60 g) for 3 minutes; the platelet-rich upper layer (~1-1.5 mL per tube) will be aspirated and applied to the defect for 5 minutes before primary closure with 4-0 monofilament sutures. Postoperative care will include analgesic and/or anti-inflammatory medication as needed and an antiseptic mouthwash; systemic antibiotics will not be routinely prescribed. Sutures will be removed at approximately 1 week. A planned follow-up schedule will include weekly visits during the first month and monthly visits thereafter through month 6.

The primary outcome will be the change in probing pocket depth (PPD) at surgical sites at 6 months. Key secondary outcomes will include clinical attachment level (CAL), plaque and gingival indices, bleeding on probing, gingival recession depth and width, patient-reported pain and sensitivity (VAS), and postoperative clinical healing parameters such as edema, erythema, and necrosis, assessed at prespecified time points. Randomization will be computer-generated; surgeries and measurements will be performed by an experienced periodontist using calibrated probes.

The study has been approved by an institutional ethics committee and will be conducted in accordance with the Declaration of Helsinki and good clinical practice principles. The trial does not involve any U.S. FDA-regulated drug or device. An independent data monitoring committee will not be convened given the low-risk, single-center nature of the interventions; adverse events will be actively assessed at follow-up visits, and participants may withdraw at any time without penalty.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06590
    • Gazi University Faculty of Dentistry, Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Diagnosis of Stage II-IV periodontitis
• Presence of ≥3 adjacent teeth with probing pocket depth (PPD) ≥5 mm
• Systemically healthy individuals
• Non-smokers
• Ability and willingness to comply with oral hygiene instructions and study follow-up visits

Exclusion Criteria:

• Systemic diseases or conditions affecting periodontal healing (e.g., uncontrolled diabetes, immunodeficiency)
• Pregnancy or lactation
• Current or previous smokers
• Use of medications that may affect periodontal status (e.g., immunosuppressants, bisphosphonates)
• Previous periodontal treatment within the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - OFD + EDTA; Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning only. No injectable platelet-rich fibrin (i-PRF) was applied.	Procedure: Open Flap Debridement (OFD); Standard periodontal surgical procedure involving full-thickness flap elevation, scaling, and root planing to eliminate inflamed tissue and reduce periodontal pocket depth.; Other Names: Periodontal Flap Surgery; Other: 24% EDTA Root Conditioning; Application of 24% neutral pH EDTA gel for 3 minutes on root surfaces to remove the smear layer and expose collagen fibers before closure.; Other Names: Ethylenediaminetetraacetic Acid Gel
Experimental: Test - OFD + EDTA + i-PRF; Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning plus application of injectable platelet-rich fibrin (i-PRF) to the surgical sites before flap closure.	Procedure: Open Flap Debridement (OFD); Standard periodontal surgical procedure involving full-thickness flap elevation, scaling, and root planing to eliminate inflamed tissue and reduce periodontal pocket depth.; Other Names: Periodontal Flap Surgery; Other: 24% EDTA Root Conditioning; Application of 24% neutral pH EDTA gel for 3 minutes on root surfaces to remove the smear layer and expose collagen fibers before closure.; Other Names: Ethylenediaminetetraacetic Acid Gel; Biological: Injectable Platelet-Rich Fibrin (i-PRF); Autologous platelet concentrate prepared by low-speed centrifugation of venous blood (~700 rpm, 3 minutes). The upper plasma fraction rich in platelets and leukocytes was aspirated and applied to defect surfaces for approximately 5 minutes before flap closure.; Other Names: Autologous Injectable PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in probing pocket depth (mm) at treated sites	Measured with a UNC-15 periodontal probe at treated sites.	Baseline and 6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical attachment level (mm) at treated sites	Measured with a UNC-15 periodontal probe.	Baseline and 6 months post-surgery
Mean Plaque Index (Silness and Löe Index, 0-3 scale)	Full-mouth plaque scores (0 = no plaque, 3 = abundant plaque). Higher scores indicate worse oral hygiene.	Baseline, 3 months, and 6 months
Mean Gingival Index (Löe and Silness Index, 0-3 scale)	Gingival inflammation scores (0 = normal gingiva, 3 = severe inflammation). Higher scores indicate worse gingival condition.	Baseline, 3 months, and 6 months
Percentage of sites with bleeding on probing (%)	Assessed by gentle probing (0 = no bleeding, 1 = bleeding present). Higher percentages indicate worse periodontal condition.	Baseline, 3 months, and 6 months
Change in gingival recession depth (mm) at treated sites	Measured vertically from the cemento-enamel junction (CEJ) to the gingival margin using a periodontal probe.	Baseline, 3 months, and 6 months
Change in gingival recession width (mm) at treated sites	Measured horizontally at the CEJ level using a periodontal probe.	Baseline, 3 months, and 6 months
Visual Analog Scale (VAS, 0-10) scores for pain and sensitivity	Patient-reported outcomes (0 = no pain/sensitivity, 10 = worst imaginable). Higher scores indicate worse symptoms.	Immediately after surgery, Week 1, and Week 2
Clinical healing parameters (edema, erythema, necrosis)	Presence or absence assessed by clinical inspection.	Week 1, Week 2, and 1 month post-surgery

Collaborators and Investigators

• Sponsor: Halil Ata BIÇAKÇIOGLU
• Investigators: Principal Investigator: HALİL A BIÇAKÇIOĞLU, PhD, Department of Periodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: October 2, 2025
• First Posted (Estimated): October 6, 2025

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Periodontitis; Immunomodulation; Platelet-Rich Fibrin; Periodontal Pocket; Autologous Blood Transfusion; Open Flap Debridement (OFD); Pro-angiogenic agents; Growth differentiation factors; Ethylenediaminetetraacetic Acid (EDTA); Root Surface Conditioning
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Periodontitis; Periodontal Pocket; Chronic Periodontitis; proliferation regulatory factors, human urine
• Other Study ID Numbers: GÜDHKAEK.2022.24/2 (Registry Identifier: Gazi University Faculty of Dentistry Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to patient privacy considerations and institutional restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No