Use of Periodontal Gel in Non-Surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
This retrospective case series included patients with stage II/III periodontitis treated with non-surgical periodontal therapy combined with a topical postbiotic gel. Clinical parameters (PD, CAL, BoP, PI) were recorded at baseline and after 8 weeks. Patients also applied the gel and a specific toothpaste at home, and outcomes were evaluated through clinical measurements and patient-reported feedback.
详细描述
This retrospective case series included patients diagnosed with stage II/III periodontitis, aged between 30 and 70 years, treated from May 2022 to September 2024. Patients were selected according to specific inclusion and exclusion criteria and provided informed consent. At baseline (T0), all subjects underwent a comprehensive periodontal examination, including full-mouth periodontal charting and radiographic assessment, with recording of clinical parameters such as probing depth (PD), clinical attachment level (CAL), bleeding on probing (BoP), and plaque index (PI).
All patients received non-surgical periodontal therapy through scaling and root planing using both manual curettes and ultrasonic instruments, following a full-mouth disinfection protocol. At the end of treatment, a postbiotic periodontal gel was prescribed for home use twice daily for 10 days, together with a toothpaste of the same formulation. Oral hygiene instructions were reinforced during follow-up, and clinical parameters were re-evaluated after 8 weeks (T1). Additionally, a questionnaire was administered to assess patient-reported outcomes regarding symptoms and treatment satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Stage II and Stage III periodontal disease
- •Subjects aged between 30 and 70 years
- •Non-smokers or light smokers (<10 cigarettes/day)
排除标准
- •Patients with Stage I or Stage IV periodontal disease
- •Current heavy smokers (≥10 cigarettes/day)
- •HbA1c > 7%
- •ASA > III
- •Patients alredy using the study products
研究组 & 干预措施
Periodontal Gel + NSPT
Adjunctive use of a gel after NSPT
干预措施: Periodontal Gel as an Adjunct to NSPT (Other)
结局指标
主要结局
Probing depth
时间窗: From enrollment to the end of treatment at 8 weeks
Probing Depth (PD), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. PD represents the distance from the gingival margin to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate deeper periodontal pockets and a worse periodontal condition.
Clinical Attachment Level (CAL)
时间窗: From enrollment to the end of treatment at 8 weeks
Clinical Attachment Level (CAL), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. CAL represents the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate greater attachment loss and a worse periodontal outcome.
次要结局
- Full Mouth Bleeding Score (FMBS)(From enrollment to the end of treatment at 8 weeks)
- Full Mouth Plaque Score (FMPS)(From enrollment to the end of treatment at 8 weeks)
- Patient Satisfaction (Questionnaire)(From enrollment to the end of treatment at 8 weeks)
研究者
Fabrizio Guerra
Associate professor, MD, pHd
University of Roma La Sapienza