Regenerative Therapy of Intrabony Periodontal Defects Using Bone Substitutes and a Minimally Invasive Nonincised Papilla Surgical Approach - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical Attachment Level (CAL) gain
研究概览
简要总结
This multicenter randomized controlled clinical trial aims to compare the clinical, radiographic, microbiological and molecular outcomes of two collagenated xenogeneic bone substitutes (GTO® and GenOs®) used in combination with the Non-Incised Papilla Surgical Approach (NIPSA) for the treatment of intrabony periodontal defects. The study will evaluate whether differences exist between the two biomaterials with respect to clinical attachment gain, defect resolution, wound healing and biological markers of regeneration.
详细描述
Background Periodontal reconstructive surgery has demonstrated favourable long-term outcomes in the treatment of intrabony periodontal defects, including challenging defects with limited remaining bony walls. Periodontitis is a chronic inflammatory disease associated with progressive destruction of the tooth-supporting tissues and alveolar bone loss. Intrabony defects are associated with an increased risk of disease progression and tooth loss and therefore represent an important therapeutic challenge.
Recent advances in minimally invasive periodontal surgery aim to improve regenerative outcomes while reducing patient morbidity. The Non-Incised Papilla Surgical Approach (NIPSA) is a minimally invasive surgical technique that provides access to the intrabony defect through an apical incision while preserving the papillary and marginal soft tissues. This approach may improve wound stability, clot protection, vascularisation, and soft tissue preservation.
In parallel, collagenated xenogeneic bone substitutes have been developed to enhance periodontal regeneration. GenOs® is a collagenated xenogeneic particulate bone substitute with a preserved collagen matrix and documented regenerative potential. GTO® is a collagenated xenogeneic bone substitute consisting of cortico-cancellous granules incorporated into a cohesive collagen gel composed of type I and III collagen. Differences in biomaterial composition and physical form may influence wound healing, tissue stability, and regenerative outcomes.
Aim The aim of this multicenter randomised controlled clinical trial is to compare the clinical, radiographic, microbiological, and molecular outcomes of GTO® and GenOs® used in combination with the NIPSA surgical approach for the treatment of intrabony periodontal defects. The study will evaluate whether the two biomaterials result in comparable improvements in periodontal regeneration and biological markers associated with bone formation and healing.
Materials and Methods This study is designed as a multicenter, parallel-group, randomised controlled clinical trial conducted at the School of Dental Medicine, University of Belgrade (Serbia), and the Department of Periodontology, University of Cagliari (Italy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Diagnosis of Stage III periodontitis
- •At least one intrabony periodontal defect with probing depth > 5 mm following completion of non-surgical periodontal therapy
- •Full-mouth plaque score (FMPS) < 20%
- •Full-mouth bleeding score (FMBS) < 20%
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Systemic medical contraindications to periodontal surgery
- •History of head and neck radiotherapy
- •Poor oral hygiene or lack of motivation/compliance
- •Uncontrolled diabetes mellitus
- •Pregnancy or lactation
- •Treatment with antiresorptive medications or other drugs affecting bone remodeling
- •Heavy smoking (>20 cigarettes/day)
结局指标
主要结局
Clinical Attachment Level (CAL) gain
时间窗: Baseline to 6 months
Change in clinical attachment level (CAL) at treated intrabony periodontal defects from baseline to 6 months following regenerative periodontal therapy using either GTO® or GenOs® in combination with the Non-Incised Papilla Surgical Approach (NIPSA).
次要结局
- Probing Depth (PD) reduction(Baseline to 6 months)
- Bleeding on Probing (BOP)(Baseline to 6 months)
- Plaque Index (PI)(Baseline to 6 months)
- Radiographic bone level changes(Baseline to 6 months)
- Quantification of periodontal pathogens(Baseline to 6 months)
- Gene expression of osteogenic markers(Baseline to 6 months)
- Gene Expression of Vascularization Markers(Baseline to 6 months)
- Growth Factor Expression(Baseline to 6 months)
- Early Healing Index (EHI)(1 week postoperatively)
- Postoperative pain and discomfort(Up to 7 days postoperatively)
研究者
Iva Milinkovic
Professor
University of Belgrade