Evaluation of Repeated Injectable PRF Following SRP in Patients With Periodontitis

NCT07029035 | Completed

• 1 other identifier: 2023/254
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a treatment called injectable platelet-rich fibrin (i-PRF) helps improve gum health in people with a type of gum disease called Stage 3 Grade B periodontitis. The main questions this study aims to answer are: Does i-PRF help reduce gum inflammation and support healing? Are there changes in certain biological markers after using i-PRF? Researchers will compare two sides of the mouth. One side will receive i-PRF, and the other will be treated with salt water (saline) as a comparison. Participants will: Have a dental cleaning called scaling and root planing (SRP) Get i-PRF injected into deep gum pockets on one side of the mouth Have salt water placed in the other side's gum pockets Give gum fluid samples and have gum measurements taken at several visits (including 3 months later) Provide a small blood sample to prepare the i-PRF Researchers will collect and study gum fluid and look at markers related to healing and inflammation. The study will help find out if i-PRF is useful as a new treatment option for gum disease.

Conditions

Periodontitis Stage III

Keywords

Tgf-β; Prf; Pf 4; Periodontitis; Pdgf; Split mouth; Mpo; İ-prf

Outcome Measures

Primary Outcomes (2)

• Changes in GCF levels of TGF-β and PDGF at multiple time points.

  Biochemical markers will be analyzed at baseline, 2 weeks, 4 weeks, and 3 months. The biochemical data will be correlated with clinical periodontal parameters to assess the relationship between molecular changes and clinical outcomes, thereby providing a comprehensive evaluation of treatment efficacy.

  From baseline to third month

• Changes in clinical periodontal parameters, including Probing Pocket Depth and Clinical Attachment Level, will be evaluated at baseline and at the third month.

  Clinical data will be evaluated at baseline and at the third month.

  From baseline to third month

Secondary Outcomes (2)

• Changes in GCF levels of PF 4 and MPO at multiple time points.

  From baseline to third month

• Changes in clinical periodontal parameters, including Plaque Index, Gingival Index, and Bleeding on Probing evaluated at baseline and at the third month.

  From baseline to third month

Study Arms (2)

Test Site

EXPERIMENTAL

Repeated application of İ-PRF to periodontal pockets in the test sites.

Biological: İnjectable platelet-rich fibrin

Control Site

SHAM COMPARATOR

Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material.

Other: Sterile saline (0.9%)

Interventions

İnjectable platelet-rich fibrin BIOLOGICAL

Repeated application of I-PRF to the periodontal pockets in the test sites was performed twice: once immediately following scaling and root planing (SRP), and once at the third week.

Test Site

Sterile saline (0.9%) OTHER

Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material.

Control Site

Eligibility Criteria

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

You may qualify if:

• Being diagnosed with Stage 3 Grade B periodontitis
• Being between the ages of 18-65

You may not qualify if:

• Smoking
• Having a systemic disease
• Taking any medication
• Being pregnant or breastfeeding
• Having received chemotherapy, radiotherapy or immunosuppressant treatments
• Having received periodontal treatment in the last 6 months
• Having used antibiotics in the last 6 months

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Health Sciences University-Scientific Research Projects Unit: collaborator

Study Sites (1)

Saglik Bilimleri Universitesi Gulhane Dis Hekimligi Fakultesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In addition to masking the participants, the researcher who performed the biochemical analyses was also masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilized a split-mouth, within-subject design rather than a classical crossover or parallel group design. Each subject received both the intervention (PRF) and control (no PRF) on different sites of the oral cavity.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 19, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2023-10

Locations

TU (1)