The Effectiveness of an Incremental Approach to Nonsurgical Periodontal Therapy With the Use of Adjunctive Slow-release Locally Administered 0.02% Hypochlorite Formulation: A Single-blind Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in full mouth bleeding score (ΔFMBS)
研究概览
简要总结
Aim: The presence of bacterial plaque is associated with the development of periodontal inflammation. The aim of this single-blind randomized clinical study was to prospectively evaluate the efficacy of two different agents in a staged approach for nonsurgical periodontal treatment in terms of clinical and patients related outcomes in a cohort of patients with periodontitis: NitrAdine® based disinfectant formula (PerioTabs®) vs Chlorhexidine 0.12 toothpaste and mouthwash 0.20.
Material and methods: Patients with a diagnosis of periodontal disease (stage I-III) scheduled for non surgical periodontal treatment were randomly allocated to the preparatory home use of a chlorhexidine mouthwash or a NitrAdine® based brushing solution called PerioTabs® for 10-15 days. Active decontamination with ultrasonic scalers was performed after the completion of the preparation period. Clinical and patient-related outcomes were recorded at baseline, at the moment of professional intervention, and after 30 and 90 days from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- 是
入选标准
- •older than 18 y.o,
- •systemically healthy,
- •with a clinical diagnosis of periodontitis
排除标准
- •alcohol or drug abuse,
- •regular drug use of bisphosphonates,
- •non-steroidal or steroidal anti-inflammatory,
- •daily antacid therapy,
- •selective serotonin reuptake inhibitors and other therapy that might affect periodontal health,
- •antibiotics during the previous 6 months,
- •smoking more than ten cigarettes per day;
- •pregnancy;
- •lactation;
- •previous periodontitis treatment within the last 6 months,
- •radiotherapy to the head or neck, current chemotherapy.
研究组 & 干预措施
PerioTabs® brushing solution
At baseline, patients were given instructions for the home use of PerioTabs® for daily gum and toothbrushing for 10 consecutive days, according to the product's directions for use. The procedure consisted of brushing the teeth and gums for 2 minutes in the evening during a 10-day period. After one week, one-stage full-mouth disinfection was performed with the use of ultrasonic devices on each quadrant. In addition, two cycles of 90 seconds ozone-therapy were carried out.
干预措施: PerioTabs® brushing solution (Combination Product)
Chlorhexidine 0.2% mouth rinse
At baseline, patients were given instructions for the home use of toothbrush with chlorhexidine 0.12 % toothpaste for 15 days toothbrushing twice daily (morning and evening). Also, a chlorhexidine 0.2% mouth rinse had to be used every evening for the course of the 15 days. After two weeks, the one-stage full-mouth disinfection was performed in the same way as in Group 1.
干预措施: Chlorhexidine 0.12 % (Combination Product)
结局指标
主要结局
change in full mouth bleeding score (ΔFMBS)
时间窗: Between baseline and the active debridement which occurred 15 days later
次要结局
未报告次要终点