Enamel-repair Microcrystal Mouthwash Enriched With an Antibacterial Complex (ABX) Versus Chlorhexidine (CHX) Mouthwash as an Adjunct to Non-surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
The study aims to compare the efficacy of a novel mouthwash based on microRepair ABX and an antibacterial complex with that of 0.12% chlorhexidine, both used as adjuncts to scaling and root planing.
详细描述
This study will be conducted in the Department of Odontostomatological and Maxillofacial sciences, in the Screening and Prevention Unit directed by me.
Study Population Subjects diagnosed with periodontal disease and requiring non-surgical periodontal therapy were enrolled.
Sample Size A total of 40 patients were included in the study, with 20 subjects allocated to each treatment group. Group A- TEST GROUP: NSPT+ ABX; GROUP B- CONTROL GROUP: NSPT+ CHX. All participants underwent a comprehensive periodontal examination, including full-mouth periodontal charting.
Standardized intraoral periapical radiographs were obtained using positioning devices to assess radiographic bone loss.
All patients subsequently received non-surgical periodontal therapy (NSPT) following a full-mouth disinfection protocol, performed with both hand and ultrasonic instruments. Oral hygiene instructions were reinforced at each scheduled visit. A first re-evaluation was conducted at 8 weeks, and a second re-evaluation at 6 months to assess periodontal stability.
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
- 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 I, II and III periodontal disease;
- •Age between 30 and 70 years;
- •ASA I or II patients;
- •Light smokers (<10 cigarettes per day);
- •Patients not already using the study products
排除标准
- •Patients with Stage IV periodontal disease;
- •HbA1c > 7% 3 ASA > III 4 Severe smokers 5 Patients already using the study products
研究组 & 干预措施
Group B - Control Group
NSPT + CHX 0,12%
干预措施: CHX as adjunctive to non surgical periodontal treatment (Other)
Group A - Test group
NSPT + ABX
干预措施: ABX Mouthwash as adjunctive to non surgical periodontal treatment (Other)
结局指标
主要结局
Probing depth
时间窗: From enrollment to the end of treatment at 12 weeks and at 24 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.
full mouth bleeding score
时间窗: from baseline to 12 and 24 weeks after full mouth disinfection
Full Mouth Bleeding Score (FMBS), expressed as the percentage (%) of sites exhibiting bleeding on probing out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate more gingival inflammation and a worse outcome.
次要结局
- dentin hypersensitivity(baseline, 12 weeks and 24 weeks)
- clinical attachment level - CAL(From baseline to 12 and 24 weeks after full mouth disinfection)
- Full mouth plaque score(from baseline to 12 and 24 weeks after full mouth disinfection)
- Patient satisfaction(2 weeks after the non surgical periodontal treatment)
研究者
Fabrizio Guerra
Associate professor, MD, pHd
University of Roma La Sapienza