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PeriodontitisNCT07363135

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

A study testing Albumin platelet-rich fibrin and Sterile saline (0.9%) in people with Periodontitis and Periodontitis (Stage 3), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Periodontitis, Periodontitis (Stage 3)
What is being tested?
Albumin platelet-rich fibrin and Sterile saline (0.9%)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Nov 2024to 1 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being diagnosed with Stage 3 Grade B periodontitis
  • Being between the ages of 18-65
  • Vertical bone defects in two quadrants

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gulhane Faculty of Dentistry, University of Health Sciences, Ankara, Turkey

    Ankara, Keçiören, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Albumin Platelet-Rich Fibrin Application Following Scaling and Root Planing on Gingival Crevicular Fluid Growth Factors in Patients With Periodontitis

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.

Read the detailed description

The study aims to investigate the effects of applying albumin platelet-rich fibrin (Alb-PRF) into periodontal pockets following scaling and root planing (SRP) on clinical, radiographic, and gingival crevicular fluid (GCF) growth factor parameters in patients with periodontitis. Periodontitis is a chronic inflammatory disease that affects the periodontal ligament and alveolar bone surrounding the teeth, leading to tooth mobility and potential tooth loss if left untreated. SRP represents the initial and most important therapeutic intervention, involving mechanical removal of plaque and calculus, as well as smoothing of root surfaces to reduce inflammation and facilitate healing. While SRP alone can decrease pocket depth and provide some clinical attachment gain, healing is often limited, generally resulting in repair through long junctional epithelium rather than true regeneration. To enhance clinical outcomes and accelerate regeneration, various adjunctive therapies, including local antibiotics, regenerative materials, photodynamic therapy, and laser treatments, have been explored and reported to provide positive effects. In recent years, autologous PRF applied into the periodontal pocket has demonstrated beneficial contributions to both clinical and biochemical parameters, as it is rich in concentrated platelets and alpha granules containing growth factors such as platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and transforming growth factor-beta (TGF-β), which collectively promote cellular proliferation, differentiation, migration, and wound healing. PRF not only delivers these growth factors but also provides a fibrin matrix that acts as a scaffold to support tissue repair. However, the clinical efficacy of PRF is limited by its relatively short duration in the tissue, with effects diminishing approximately 10 days after application, and absorption occurring within a short time frame. To overcome these limitations, a modified approach has been developed in which the upper plasma fraction (platelet poor plasma, PPP) is heat-treated and mixed with the middle PRF layer to produce an Alb-PRF. This material demonstrates prolonged residence in tissue, delayed resorption, and sustained release of growth factors, while also exhibiting improved mechanical properties compared to conventional PRF. In the present study, 23 patients diagnosed with generalized Stage III Grade B periodontitis based on clinical and radiographic examinations will be enrolled. Eligible participants are adults without systemic diseases, not using medications, non-smokers, and not pregnant or breastfeeding, and who have not received periodontal therapy within the past six months. A randomized controlled split-mouth design will be implemented, with one side of the mouth serving as the test site receiving SRP+Alb-PRF, and the contralateral side serving as the control site receiving SRP alone. Clinical periodontal indices, including plaque index, gingival index, bleeding on probing, probing pocket depth, clinical attachment level, and gingival recession, will be recorded at baseline, 3 months, and 6 months. Radiographic assessment of defect depth, percentage of root involvement, and defect angles will be performed at baseline and 6 months. GCF samples will be collected from the deepest pockets at baseline and on days 7, 14, and 21 post-treatment, isolated using periostrips following removal of supragingival plaque, and analyzed for PDGF-BB, VEGF, b-FGF, and TGF-β concentrations using ELISA at the Gülhane Training and Research Hospital Biochemistry Department. Blood for preparation of Alb-PRF will be drawn from the antecubital vein, centrifuged to separate layers, and the upper plasma fraction heated and mixed with injectable PRF using a three-way serum kit to produce the gel, which will then be carefully applied to deep pockets in the test region without overflow. Clinical, radiographic, and biochemical outcomes will be statistically analyzed using SPSS software, employing paired tests such as dependent t-tests, Wilcoxon, and Friedman tests for intra-subject comparisons, with Pearson correlation analysis for continuous variables, and a significance threshold of p<0.05. The sample size of 23 patients (providing 46 test and control sites) was calculated based on previous studies to achieve 95% statistical power. The investigators hypothesized that Alb-PRF application will result in superior clinical attachment gain and prolonged expression of growth factors compared to SRP alone, thus potentially enhancing both soft tissue and alveolar bone regeneration.

Being tested
Albumin platelet-rich fibrin, Sterile saline (0.9%)
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
Medical subject headings
Periodontitis, Camurati-Engelmann Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albumin platelet-rich fibrinProcedure or surgery

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

  • 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.

Study groups in NCT07363135
Study groupRoleWhat they receive
Test SiteExperimentalApplication of Alb-PRF to periodontal pockets in the test sites.
Receives: Procedure: Albumin platelet-rich fibrin
Control SiteSham comparatorControl 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.
Receives: Other: Sterile saline (0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Probing Pocket Depth (PPD)

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

    Measured: Baseline, 3 months, and 6 months

  2. Change in Clinical Attachment Level (CAL)

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

    Measured: Baseline, 3 months, and 6 months

  3. 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.

    Measured: Baseline, Day 7, Day 14, Day 21

  4. 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.

    Measured: Baseline, Day 7, Day 14, Day 21

  5. 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

    Measured: Baseline, Day 7, Day 14, Day 21

  6. 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.

    Measured: Baseline, Day 7, Day 14, Day 21

Secondary outcomes (7)
  1. Change in Plaque Index Score

    Change in plaque index score assessed at baseline, 3 months, and 6 months following treatment.

    Measured: Baseline, 3 months, and 6 months

  2. Change in Gingival Index Score

    Change in gingival index score assessed using at baseline, 3 months, and 6 months following treatment.

    Measured: Baseline, 3 months, and 6 months

  3. Change in Bleeding on Probing Percentage (%)

    Change in bleeding on probing expressed as a percentage of bleeding sites assessed at baseline, 3 months, and 6 months following treatmen

    Measured: Baseline, 3 months, and 6 months

  4. Change in Gingival Recession (mm)

    Change in gingival recession measured in millimeters from the cemento-enamel junction (CEJ) to the gingival margin at baseline, 3 months, and 6 months following treatment

    Measured: Baseline, 3 months, and 6 months

  5. Change in Radiographic Bone Defect Depth (mm)

    Change in bone defect depth measured on standardized periapical radiographs as the vertical distance from the cemento-enamel junction (CEJ) to the base of the defect at baseline and 6 months following treatment.

    Measured: Baseline and 6 months

  6. Change in Radiographic Bone Loss Percentage Relative to Root Length (%)

    Change in radiographic bone loss percentage calculated relative to root length. Root length was defined as the distance from the cemento-enamel junction (CEJ) to the point where a line drawn parallel to the long axis of the tooth intersected a horizontal line passing through the root apex, measured at baseline and 6 months.

    Measured: Baseline and 6 months

  7. Change in Radiographic Bone Defect Angle (degrees, °)

    Change in the radiographic bone defect angle measured on standardized periapical radiographs at baseline and 6 months following treatment. The defect angle was defined as the angle between a line drawn parallel to the long axis of the tooth and a line connecting the cemento-enamel junction (CEJ) to the base of the bone defect.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start20 Nov 2024
  3. Primary completion15 Oct 2025
  4. Study completion1 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363135
Sponsor's protocol ID
2023/248A
Status last verified
Nov 2025
First submitted
16 Dec 2025
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ozcan E, Ulu Emir B, Avci E, Ozarslanturk S, Bahar SC. Effects of albumin-platelet-rich fibrin as an adjunct to non-surgical periodontal therapy in patients with periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2026 Jun 2. doi: 10.1186/s12903-026-08677-w. Online ahead of print.

    PubMed 42231297

Questions about this trial

What is this clinical trial studying?

A study testing Albumin platelet-rich fibrin and Sterile saline (0.9%) in people with Periodontitis and Periodontitis (Stage 3), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Probing Pocket Depth (PPD) (time frame: Baseline, 3 months, and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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