The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- probing pocket depth
研究概览
简要总结
The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with generalized (>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers
- •A minimum of three natural teeth in each quadrant, excluding third molars
- •Willing and able to give informed consent
- •Not more than 50% of the patients in each group will be smokers.
- •Smokers should smoke between 10 to 40 cigarettes a day
排除标准
- •Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier
- •Patients with orthodontic appliances (removable or fixed)
- •Pregnant or lactating woman
- •Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies
- •Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
- •Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage
- •Participation in any other clinical study
- •Tobacco chewing or sniffing
研究组 & 干预措施
Active Chx
This group will receive active chlorhexidine and placebo probiotics
干预措施: active chlorhexidine and placebo probiotic (Combination Product)
Active probiotics
This group will receive placeo chlorhexidine and active probiotics
干预措施: placebo chlorhexidine and active probiotic (Combination Product)
Active Chx & probiotics
This group will receive active chlorhexidine and active probiotics
干预措施: active chlorhexidine and active probiotic (Combination Product)
结局指标
主要结局
probing pocket depth
时间窗: 6 months
the distance between gingival margin and pocket base in millimeters
次要结局
- percentage of patients in low risk for disease progression(6 months)
- gingival recession(6 months)
- clinical attachment level(6 months)
- full mouth bleeding and plaque score(6 months)
- microbial outcomes(6 months)
研究者
Mustafa Ozcan
Associate professor
Cukurova University