The Adjunctive Effect of a Mucoadhesive Polymeric Hydrogel to Non-surgical Periodontal Therapy: a Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
This retrospective observational study will evaluate the clinical response to Sterify Gel, a sterile mucoadhesive polymeric hydrogel, when used as an adjunct to non-surgical periodontal therapy in adult patients with stage II, III, or IV periodontitis.
The study will analyze already existing anonymized clinical records from patients treated at the Periodontal Unit of IRCCS Ospedale San Raffaele in Milan, Italy. Patients included in the analysis received scaling and root planing/minimally invasive non-surgical periodontal therapy, followed by local application of Sterify Gel into periodontal pockets with probing depth greater than 4 mm.
The main objective is to assess reduction in periodontal pocket depth from baseline to 6, 12, and 24 weeks. Other periodontal clinical parameters, including clinical attachment level, gingival recession, bleeding, plaque score, tooth mobility, and furcation involvement, will also be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged >18 years
- •Diagnosis of stage II, III, or IV periodontitis
- •Non-smokers
- •Negative medical history
- •Patients treated with scaling and root planing/minimally invasive non-surgical periodontal therapy plus mucoadhesive polymeric hydrogel
- •Patients enrolled in supportive periodontal care
排除标准
- •Pregnancy
- •Surgical re-treatment during the maintenance period
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: Baseline, 6 weeks, 12 weeks, and 24 weeks
Change in probing pocket depth from baseline to 6, 12, and 24 weeks in treated periodontal pockets with baseline PPD greater than 4 mm.
次要结局
未报告次要终点
研究者
Rotundo Roberto
Principal Investigator
IRCCS San Raffaele