Alb-PRF as an Adjunct to Regenerative Periodontal Surgery

N/ANot Yet RecruitingNCT07805317

Halil Ata BIÇAKÇIOĞLU24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontitis Periodontitis Stage III

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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

Oral Health-Related Quality of Life

Oral health-related quality of life will be evaluated using the 14-item Oral Health Impact Profile. Each item is scored from 0 to 4, producing a total score ranging from 0 to 56. Lower total scores indicate a lower negative impact of oral health conditions on quality of life.

Time frame: Baseline, Day 14, and 9 months

Plaque Index Score

Plaque accumulation will be assessed using the Silness and Löe Plaque Index. Each evaluated surface will be scored from 0 to 3, where 0 indicates the absence of plaque and 3 indicates abundant plaque accumulation. Lower scores indicate better plaque control.

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

Gingival Index Score

Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each evaluated surface will be scored from 0 to 3 according to changes in gingival color, consistency, and bleeding response. Lower scores indicate less gingival inflammation.

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

Gingival Recession Depth

Gingival recession depth will be measured in millimeters at the treated tooth as the apicocoronal distance from the cementoenamel junction to the gingival margin using a calibrated periodontal probe. Higher values indicate greater apical displacement of the gingival margin.

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

Gingival Recession Width

Gingival recession width will be measured in millimeters at the treated tooth as the mesiodistal width of the exposed root surface at the level of the cementoenamel junction using a calibrated periodontal probe. Higher values indicate a wider gingival recession defect.

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

Alb-PRF as an Adjunct to Regenerative Periodontal Surgery

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts