Evaluation of Subgingival Mechanical Periodontal Therapy With the Additional Local Application of a Spermidine-Based Gel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes in probing depth (PD)
研究概览
简要总结
This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.
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 (Investigator, 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
- 否
入选标准
- •Age 18 years or older. Presence of untreated periodontitis with at least 2 sites showing clinical attachment loss (CAL) > 2 mm and probing depth (PD) > 4 mm.
- •Voluntary signing of informed consent.
排除标准
- •Presence of systemic diseases (e.g., diabetes mellitus, cardiovascular, renal, hepatic, or pulmonary conditions).
- •Smokers (≥10 cigarettes per day). Pregnancy or breastfeeding. Allergy to any ingredients in the products used in the study. Diseases affecting bone and/or connective tissue metabolism.
研究组 & 干预措施
MINST plus spermidine gel
干预措施: spermidine and minimally invasive non surgical tecnique (Procedure)
MINST (minimally invasive non surgical tecnique)
干预措施: peridontal therapy (minimally invasive non surgical tecnique) (Other)
结局指标
主要结局
Changes in probing depth (PD)
时间窗: From non surgical periodontal therapy to 6 months
variations in periodontal probing depth between baseline and follow-up
次要结局
未报告次要终点
研究者
Luca Ramaglia
Professor
Federico II University