Comparative effectiveness of probiotic toothpaste and fluoridated toothpaste as adjuncts to scaling and root planing on red complex bacteria in stage II periodontitis: A randomized controlled superiority trial in a tertiary care setting
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving a negative result for red complex bacteria at 1 month following intervention, as assessed by the AMA DENT Point-of-Care (POC) test.
研究概览
简要总结
Primary purpose of this protocol is to evaluate whether probiotic toothpaste containing Bacillus coagulans is superior to regular fluoridated toothpaste when used as an adjunct to scaling and root planing in patients with Stage II periodontitis. The study aims to determine if the probiotic toothpaste results in at least a 25 percentage point greater reduction in the proportion of participants testing negative for red complex bacteria after one month. The hypothesis is that probiotic toothpaste will produce a clinically significant improvement in microbiological and periodontal outcomes compared to fluoridated toothpaste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with Stage II periodontitis based on 2017 World Workshop classification criteria Presence of at least 20 natural teeth excluding third molars and teeth indicated for extraction Moderate plaque levels at baseline Willing to undergo scaling and root planing Able and willing to provide written informed consent.
排除标准
- •Presence of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunosuppression, chronic kidney disease).
- •Pregnant or lactating women.
- •Current smokers or former smokers within the last 5 years.
- •Use of antibiotics, antimicrobials, long-term anti-inflammatory drugs, or immunosuppressants within the past 3 months.
- •History of allergy or hypersensitivity to any component of the study toothpastes.
- •Periodontal treatment within the last 6 months.
- •Regular consumption of probiotic supplements or probiotic-containing products within the last 3 months.
结局指标
主要结局
Proportion of participants achieving a negative result for red complex bacteria at 1 month following intervention, as assessed by the AMA DENT Point-of-Care (POC) test.
时间窗: baseline to 1 month
The outcome will be recorded as a binary variable (Positive/Negative) and compared between the probiotic toothpaste and fluoridated toothpaste groups.
时间窗: baseline to 1 month
次要结局
- Change in Gingival Index (GI) from baseline to 1 month.
研究者
Dr Anoop S
Government Dental College