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NCT07805317

Alb-PRF as an Adjunct to Regenerative Periodontal Surgery

Sponsor: Halil Ata BIÇAKÇIOĞLU

View on ClinicalTrials.gov

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.

Official title: Clinical and Radiographic Effects of Albumin Platelet-Rich Fibrin as an Adjunct to Regenerative Periodontal Surgery: A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01-01

Completion Date

2028-09-01

Last Updated

2026-09-04

Healthy Volunteers

Conditions

Periodontitis Periodontitis Stage III Periodontal Intrabony Defects

Interventions

PROCEDURE

Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft

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.

OTHER

Albumin Platelet-Rich Fibrin

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (2)

Gazi University Faculty of Dentistry, Department of Periodontology

Ankara, Ankara, Turkey (Türkiye)

Çankırı Karatekin University Faculty of Dentistry, Department of Periodontology

Çankırı, Çankırı, Turkey (Türkiye)