Evaluation of Albumin Platelet-Rich Fibrin Following SRP in Patients With Periodontitis

NCT07363135 | Completed

• 1 other identifier: 2023/248A
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate whether application of albumin platelet-rich fibrin (Alb-PRF) into the gum pockets after scaling and root planing (SRP) can improve healing in patients with Stage III Grade B periodontitis. Periodontitis is a chronic disease that damages the tissues and bone surrounding the teeth and can lead to tooth loosening or loss if untreated. SRP is the first and most important treatment step, cleaning the tooth surfaces and smoothing the roots to reduce inflammation, but healing is often limited. PRF, made from the patient's own blood, is rich in platelets and growth factors that support tissue repair, and Alb-PRF is a new form that stays longer in the pocket and releases growth factors over time. In this study, 23 patients who meet the inclusion criteria (adults without systemic diseases, not using medications, non-smokers, not pregnant or breastfeeding, and not recently treated for periodontitis) will participate in a split-mouth design, where one side of the mouth receives SRP+ Alb-PRF and the other side receives SRP alone. Clinical measurements, including plaque, gum inflammation, bleeding, pocket depth, gum recession, and attachment levels, will be taken at baseline, 3 months, and 6 months, while X-rays will assess bone defects at baseline and 6 months. Additionally, gingival crevicular fluid (GCF) will be collected from the deepest pockets at baseline and on days 7, 14, and 21 to measure growth factors in the laboratory. Blood from patients will be processed to prepare the albumin-PRF gel, which will be carefully applied to the deep pockets on the test side. The investigators expect that pockets treated with albumin-PRF gel will show greater clinical attachment gain and higher, longer-lasting growth factor levels, potentially leading to improved gum and bone healing compared to SRP alone.

Conditions

Periodontitis; Periodontitis (Stage 3)

Keywords

periodontitis; prf; platelet rich-fibrin; Non-surgical periodontal treatment; Albumin prf; platelet-derived growth factor; vascular endothelial growth factor; basic fibroblast growth factor; transforming growth factor-beta

Outcome Measures

Primary Outcomes (6)

• Change in Probing Pocket Depth (PPD)

  Change in probing pocket depth (mm) measured at baseline, 3 months, and 6 months following treatment.

  Baseline, 3 months, and 6 months

• Change in Clinical Attachment Level (CAL)

  Change in clinical attachment level (mm) measured at baseline, 3 months, and 6 months following treatment.

  Baseline, 3 months, and 6 months

• Concentration of PDGF-BB in Gingival Crevicular Fluid

  PDGF-BB concentration (pg/mL) measured in gingival crevicular fluid at baseline and on days 7, 14, and 21 following treatment.

  Baseline, Day 7, Day 14, Day 21

• Concentration of VEGF in Gingival Crevicular Fluid

  VEGF concentration (pg/mL) measured in gingival crevicular fluid at baseline and on days 7, 14, and 21 following treatment.

  Baseline, Day 7, Day 14, Day 21

• Concentration of b-FGF in Gingival Crevicular Fluid

  b-FGF concentration (pg/mL) measured in gingival crevicular fluid at baseline and on days 7, 14, and 21 following treatment

  Baseline, Day 7, Day 14, Day 21

• Concentration of TGF-β in Gingival Crevicular Fluid

  TGF-β concentration (pg/mL) measured in gingival crevicular fluid at baseline and on days 7, 14, and 21 following treatment.

  Baseline, Day 7, Day 14, Day 21

Secondary Outcomes (7)

• Change in Plaque Index Score

  Baseline, 3 months, and 6 months

• Change in Gingival Index Score

  Baseline, 3 months, and 6 months

• Change in Bleeding on Probing Percentage (%)

  Baseline, 3 months, and 6 months

• Change in Gingival Recession (mm)

  Baseline, 3 months, and 6 months

• Change in Radiographic Bone Defect Depth (mm)

  Baseline and 6 months

Study Arms (2)

Test Site

EXPERIMENTAL

Application of Alb-PRF to periodontal pockets in the test sites.

Procedure: Albumin 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

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

Albumin platelet-rich fibrin PROCEDURE

Application of Alb-PRF to the periodontal pockets in the test sites.

Test Site

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• 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
• Vertical bone defects in two quadrants

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
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Gulhane Faculty of Dentistry, University of Health Sciences, Ankara, Turkey

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: PARALLEL
• 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 (Alb-PRF) and control (no Alb-PRF) on different sites of the oral cavity.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 23, 2026
• Study Start: November 20, 2024
• Primary Completion: October 15, 2025
• Study Completion: February 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-11

Locations

TU (1)