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Alb-PRF as an Adjunct to Regenerative Periodontal Surgery

ConditionsPeriodontitisPeriodontitis Stage IIIPeriodontal Intrabony Defects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHalil Ata BIÇAKÇIOĞLU

About this trial

Periodontitis is characterized by the progressive destruction of tooth-supporting tissues and may lead to the formation of intrabony periodontal defects. Regenerative periodontal surgery aims to promote the reconstruction of the periodontal attachment apparatus and reduce residual defect dimensions. Albumin platelet-rich fibrin (Alb-PRF) is an autologous blood-derived biomaterial that combines an albumin-based matrix with platelet-rich fibrin components.

This randomized controlled clinical trial will evaluate the clinical and radiographic effects of Alb-PRF as an adjunct to regenerative periodontal surgery in patients with periodontitis-associated intrabony defects. Twenty-four participants will be randomly allocated to two parallel treatment groups. Both groups will undergo regenerative periodontal surgery involving defect debridement, root surface conditioning with EDTA, and placement of an allogeneic bone graft. In the experimental group, Alb-PRF will additionally be applied to the intrabony defect.

The primary outcome will be clinical attachment level gain at 6 months. Secondary outcomes will include probing depth, radiographic defect fill, early wound healing, postoperative pain, oral health-related quality of life, and adverse events. Participants will be followed for 9 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 65 years.

Diagnosis of Stage III periodontitis according to the 2017 classification of periodontal and peri-implant diseases and conditions.

Completion of nonsurgical periodontal therapy and oral hygiene instruction before surgical treatment.

Presence of at least one interproximal intrabony periodontal defect considered suitable for regenerative periodontal surgery.

Disqualifiers

Current smoking or smoking cessation within the previous 6 months.

Uncontrolled diabetes mellitus, serious cardiovascular disease, autoimmune disease, liver or kidney failure, immunodeficiency, or another systemic condition that may adversely affect periodontal healing or surgical treatment.

Pregnancy or lactation.

Presence of a hematologic disorder, bleeding disorder, anticoagulant therapy, or another condition that may interfere with venous blood collection or periodontal surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft

    Procedure/Surgery

    Following local anesthesia, a periodontal flap will be elevated to provide access to the intrabony defect. Granulation tissue will be removed, and the exposed root surface will be thoroughly debrided and conditioned with EDTA. An allogeneic bone graft will then be placed within the defect, and the surgical site will be closed using appropriate suturing techniques. This intervention will be administered to participants in both study arms.

  • Albumin Platelet-Rich Fibrin

    Other intervention

    Alb-PRF will be prepared from autologous venous blood using a standardized centrifugation and albumin-processing protocol. The resulting albumin-based platelet-rich fibrin biomaterial will be combined with or applied in conjunction with the allogeneic bone graft and placed within the intrabony periodontal defect during regenerative periodontal surgery.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Regenerative Periodontal Surgery With Allogeneic Bone GraftActive comparator 1 intervention
Group B: Regenerative Periodontal Surgery With Allogeneic Bone Graft and Alb-PRFExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Clinical Attachment Level Gain

Clinical attachment level will be measured in millimeters at the treated intrabony defect site from the cementoenamel junction to the base of the periodontal pocket using a calibrated periodontal probe. Clinical attachment level gain will be calculated as the baseline value minus the 6-month value. Higher positive values indicate greater clinical attachment gain.

Time frame
Baseline to 6 months

Secondary outcomes

1

Probing Depth Reduction

Probing depth will be measured in millimeters at the treated intrabony defect site from the gingival margin to the base of the periodontal pocket using a calibrated periodontal probe. Probing depth reduction will be calculated as the baseline value minus the value recorded at each follow-up visit. Higher positive values indicate greater probing depth reduction.

Time frame
Baseline, 3 months, 6 months, and 9 months
2

Radiographic Intrabony Defect Fill

Radiographic intrabony defect depth will be measured on standardized digital periapical radiographs obtained at baseline and 9 months. Defect fill will be calculated as the reduction in radiographic defect depth relative to the baseline defect depth and expressed as a percentage. Higher percentages indicate greater radiographic defect fill.

Time frame
Baseline to 9 months
3

Early Healing Index Score

Early postoperative wound healing will be evaluated using the Early Healing Index. The index ranges from 1 to 5 and assesses flap closure, fibrin formation, and the presence of tissue necrosis at the surgical site. Lower scores indicate more favorable early wound healing.

Time frame
14 days after surgery
4

Postoperative Pain Intensity

Postoperative pain intensity will be assessed using a visual analog scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Lower scores indicate less postoperative pain.

Time frame
Day 0, Day 7, and Day 14 after surgery

Other outcomes

1

Treatment-Related Adverse Events

Participants will be monitored for treatment-related adverse events, including postoperative infection, excessive or prolonged bleeding, marked swelling, wound dehiscence, graft exposure, delayed healing, and any other unexpected complication associated with the surgical procedure or Alb-PRF application. The number and proportion of participants experiencing at least one adverse event will be recorded.

Time frame
From the surgical procedure through 9 months

Sponsors and contacts

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Halil Ata BIÇAKÇIOĞLU

Lead sponsor

Çankırı Karatekin University

Sponsor institution

Gazi University

Collaborator

Çankırı Karatekin University

Collaborator

Source ClinicalTrials.gov

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