Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Clinical Attachment Level gain (CAL, mm)
研究概览
简要总结
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
详细描述
This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.
Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.
Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •Good compliance and good oral hygiene
- •Systemically healthy
- •Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- •The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
排除标准
- •Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- •Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- •Systemic diseases that would adversely influence wound healing
- •Medications interfering with post-operative wound healing
- •Pregnant and lactating females
- •Previous periodontal surgery in the examined area
- •III-degree mobility
- •Furcation involvement
- •Pulpal pathology or inadequate endodontic treatment
结局指标
主要结局
Clinical Attachment Level gain (CAL, mm)
时间窗: 6 months and 12 months
Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
次要结局
- Gingival Recession (GR, mm)(Baseline, 6 months and 12 months)
- Probing Pocket Depth (PPD, mm)(Baseline, 6 months and 12 months)
- Probing Pocket Depth reduction (PPD, mm)(6 months and 12 months)
- Clinical Attachment Level (CAL, mm)(Baseline, 6 months, and 12 months)
- Keratinized Tissue Width (KTW, mm)(Baseline, 6 months and 12 months)
- Gingival Thickness (GT, mm)(Baseline, 6 months and 12 months)
- Soft Tissue Volumetric Change (mm³)(6 months and 12 months)
- Radiographic Linear Defect Fill (LDF, mm)(6 months and 12 months)
- Radiographic Percentage Defect Fill (%DF)(6 months and 12 months)
- Early Wound Healing Score (EHS)(1 week and 2 weeks)
- Full-Mouth Plaque Score (FMPS, %)(Baseline, 6 months, and 12 months)
- Full-Mouth Bleeding Score (FMBS, %)(Baseline, 6 months, and 12 months)