Comparative Evaluation of Albumin Platelet-Rich Fibrin and Advanced Platelet-Rich Fibrin in Periodontal Regeneration: A Clinical and Radiological Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Clinical Attachment Level (CAL) Gain – Measured using a UNC-15 periodontal probe at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
研究概览
简要总结
Periodontal regeneration remains a significant challenge due to the limitations of conventional therapies, such as bone grafts and guided tissue regeneration, which often exhibit rapid resorption, unpredictable healing, and inadequate bioactive molecule release necessary for sustained tissue repair.
Platelet-rich fibrin (PRF), and autologous biomaterial, has shown promise in enhancing cellular migration, proliferation, and differentiation. However, conventional PRF lacks mechanical stability, degrades rapidly, and has inconsistent growth factor release, limiting its regenerative potential.
To address these limitations, Advanced Platelet-Rich Fibrin (A-PRF) and Albumin Platelet-rich fibrin (Alb-PRF) have been developed. Alb-PRF, in particular, offers enhanced fibrin network stability, prolonged degradation resistance, and sustained release of growth factors such as PDGF, TGF-beta, and VEGF, which are crucial for periodontal regeneration. The incorporation of albumin further strengthens the fibrin matrix, extending its bioactivity and resorption period, potentially leading to superior clinical outcomes.
Despite these advantages, there is limited comparative evidence on the clinical and radiological efficacy of Alb-PRF as compared with A-PRF in periodontal regeneration. This study aims to fill this gap by systematically evaluating and comparing their regenerative potential to Leucocyte Platelet-rich fibrin, the gold standard in periodontal regenerative therapy.
Additionally, cone-beam computed tomography (CBCT) will be utilized to provide precise, three-dimensional volumetric assessments of bone regeneration, offering greater accuracy than conventional radiographic findings.
The findings of this study will contribute to evidence-based periodontal therapy, potentially guiding the development of more effective biomaterial-based regenerative strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Stage III Periodontitis Diagnosis: Patients with moderate to severe periodontitis with at least one tooth exhibiting a two-wall, three-wall, or combined two- and three-wall intrabony defect measuring greater than or equal to 3 mm in depth.
- •Clinical Attachment Loss and Pocket Depth: Presence of CAL measuring greater than or equal to 5 mm and PPD measuring greater than or equal to 6 mm.
- •Exclusion of Furcation Defects Vital Teeth Medication and Antibiotic History No Recent Periodontal Therapy Informed Consent Age Range: Only individuals aged 18–60 years.
- •Patient Compliance Systemic Health Status: Participants must be systemically healthy.
排除标准
- •Patients undergoing orthodontic treatment Pregnant and breastfeeding women Menopausal and postmenopausal Smokers Teeth with mobility greater than Grade 1 Patients with systemic comorbidities (e.g., Type 2 diabetes mellitus, hypertension) Patients with a history of recent periodontal surgery.
结局指标
主要结局
1. Clinical Attachment Level (CAL) Gain – Measured using a UNC-15 periodontal probe at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
时间窗: All primary outcomes are measured at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
2. Probing Pocket Depth (PPD) Reduction – Evaluated at the same time intervals to determine the extent of periodontal healing and reduction in periodontal pocket depth.
时间窗: All primary outcomes are measured at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
3. Radiographic Bone Fill – Assessed using Cone-Beam Computed Tomography (CBCT) to compare pre- and postoperative bone levels within intrabony defects.
时间窗: All primary outcomes are measured at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
次要结局
- Early Soft Tissue Healing(Evaluated using the Wound Healing Index (WHI) at 1st week, 2nd week, and 4th week postoperatively to assess the progression of soft tissue repair.)
- Gingival Index (GI)(Assessed to determine the degree of gingival inflammation tissue response at baseline, 3 months, and 6 months.)
- Plaque Index (PI)(Measured to evaluate biofilm accumulation and its impact on periodontal healing over time.)
- Bleeding on Probing (BOP)(Recorded at each follow-up visit to assess the degree of inflammation and vascular response)
- Bone Density Analysis(Assessed via CBCT at baseline, 3 months, and 6 months to evaluate changes in bone quality and mineralization)
- Crestal Bone Loss Measurement(Determined using standardized radiographic analysis to quantify marginal bone changes around the defect site.)
研究者
Amanda Antoinette Rebello
Kalinga Institute of Dental Sciences, KIIT (Deemed to be University)