i-PRF & Root Surface Biomodification

NCT07207668 | Completed

• 1 other identifier: GÜDHKAEK.2022.24/2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Periodontitis (Disorder); Periodontitis

Keywords

Open Flap Debridement (OFD); Pro-angiogenic agents; Growth differentiation factors; Immunomodulation; Ethylenediaminetetraacetic Acid (EDTA); Periodontitis; Periodontal Pocket; Root Surface Conditioning; Platelet-Rich Fibrin; Autologous Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in clinical attachment level (mm) at treated sites

  Baseline and 6 months post-surgery

• Mean Plaque Index (Silness and Löe Index, 0-3 scale)

  Baseline, 3 months, and 6 months

• Mean Gingival Index (Löe and Silness Index, 0-3 scale)

  Baseline, 3 months, and 6 months

• Percentage of sites with bleeding on probing (%)

  Baseline, 3 months, and 6 months

• Change in gingival recession depth (mm) at treated sites

  Baseline, 3 months, and 6 months

Study Arms (2)

Control - OFD + EDTA

ACTIVE COMPARATOR

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); Other: 24% EDTA Root Conditioning

Test - OFD + EDTA + i-PRF

EXPERIMENTAL

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); Other: 24% EDTA Root Conditioning; Biological: Injectable Platelet-Rich Fibrin (i-PRF)

Interventions

Open Flap Debridement (OFD) PROCEDURE

Standard periodontal surgical procedure involving full-thickness flap elevation, scaling, and root planing to eliminate inflamed tissue and reduce periodontal pocket depth.

Also known as: Periodontal Flap Surgery

Control - OFD + EDTA; Test - OFD + EDTA + i-PRF

24% EDTA Root Conditioning OTHER

Application of 24% neutral pH EDTA gel for 3 minutes on root surfaces to remove the smear layer and expose collagen fibers before closure.

Also known as: Ethylenediaminetetraacetic Acid Gel

Control - OFD + EDTA; Test - OFD + EDTA + i-PRF

Injectable Platelet-Rich Fibrin (i-PRF) BIOLOGICAL

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.

Also known as: Autologous Injectable PRF

Test - OFD + EDTA + i-PRF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Halil Ata BIÇAKÇIOGLU: lead

Study Sites (1)

Gazi University Faculty of Dentistry, Department of Periodontology

Ankara, 06590, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Periodontal Pocket

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• HALİL A BIÇAKÇIOĞLU, PhD

  Department of Periodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group allocation; however, investigators and outcome assessors were not blinded due to the surgical nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, PhD, Department of Periodontology, Gazi University Faculty of Dentistry

Model Details: This is a single-center, randomized, parallel-group trial. Both groups received open flap debridement with 24% EDTA root surface conditioning. In the test group, injectable platelet-rich fibrin (i-PRF) was additionally applied to the surgical sites, whereas in the control group no i-PRF was used. The only difference between groups was the adjunctive use of i-PRF.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 6, 2025
• Study Start: February 1, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)