Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Clinical and Radiographic Effects of Albumin Platelet-Rich Fibrin as an Adjunct to Regenerative Periodontal Surgery: A Randomized Controlled Clinical Trial
1 other identifier
interventional
24
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2027
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 4, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
September 4, 2026
September 1, 2026
1.4 years
September 1, 2026
September 1, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline to 6 months
Secondary Outcomes (9)
Probing Depth Reduction
Baseline, 3 months, 6 months, and 9 months
Radiographic Intrabony Defect Fill
Baseline to 9 months
Early Healing Index Score
14 days after surgery
Postoperative Pain Intensity
Day 0, Day 7, and Day 14 after surgery
Oral Health-Related Quality of Life
Baseline, Day 14, and 9 months
- +4 more secondary outcomes
Other Outcomes (1)
Treatment-Related Adverse Events
From the surgical procedure through 9 months
Study Arms (2)
Regenerative Periodontal Surgery With Allogeneic Bone Graft
ACTIVE COMPARATORParticipants allocated to the active comparator arm will undergo regenerative periodontal surgery. Following flap elevation and defect debridement, the root surface will be conditioned with EDTA, and an allogeneic bone graft will be placed within the intrabony periodontal defect.
Regenerative Periodontal Surgery With Allogeneic Bone Graft and Alb-PRF
EXPERIMENTALParticipants allocated to the experimental arm will undergo the same regenerative periodontal surgical procedure, including flap elevation, defect debridement, EDTA root surface conditioning, and placement of an allogeneic bone graft. Alb-PRF prepared from autologous venous blood will additionally be applied to the intrabony periodontal defect.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Residual probing depth of at least 6 mm and clinical attachment loss of at least 6 mm at the selected site following nonsurgical periodontal therapy.
- Radiographic evidence of an intrabony defect component of at least 3 mm at the selected site.
- Adequate plaque control and compliance with oral hygiene instructions.
- Ability to understand the study procedures, provide written informed consent, and attend all scheduled follow-up visits.
You may not qualify if:
- 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.
- Use of antibiotics, systemic corticosteroids, immunosuppressive agents, bisphosphonates, antiresorptive agents, or other medications known to affect periodontal or bone healing within the previous 6 months.
- Periodontal surgical treatment at the selected site within the previous 6 months.
- Acute periodontal or endodontic infection at the selected site.
- Untreated endodontic lesions, root fractures, extensive caries, or a hopeless prognosis involving the selected tooth.
- Class II or III furcation involvement associated with the selected defect.
- Known hypersensitivity to any material used in the study.
- Inadequate oral hygiene or inability to meet the plaque-control requirements of the study protocol.
- Current orthodontic treatment.
- Inability or unwillingness to attend the scheduled follow-up visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Halil Ata BIÇAKÇIOĞLUlead
- Gazi Universitycollaborator
- Çankırı Karatekin Universitycollaborator
Study Sites (2)
Gazi University Faculty of Dentistry, Department of Periodontology
Ankara, Ankara, 06490, Turkey (Türkiye)
Çankırı Karatekin University Faculty of Dentistry, Department of Periodontology
Çankırı, Çankırı, 18100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halil Ata Bıçakçıoğlu, PhD
Çankırı Karatekin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Clinical measurements and radiographic analyses will be performed by an examiner blinded to group allocation. The surgeon cannot be masked because of the nature of the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Department of Periodontology
Study Record Dates
First Submitted
September 1, 2026
First Posted
September 4, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
September 4, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data and supporting information will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
- Access Criteria
- Data may be provided to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator and the relevant institution. Access will be granted for approved scientific purposes following ethics committee and institutional requirements and, where applicable, execution of a data use agreement.
De-identified individual participant data underlying the results reported in the primary publication will be made available upon reasonable request. Shared data may include baseline characteristics, treatment allocation, clinical and radiographic outcome data, patient-reported outcome data, and adverse event information. Data sharing will be subject to ethics committee requirements and institutional approval.