Clinical Evaluation of the Antibacterial Activity of Thioglycosides Extracted from White Mustard - Bamberka in Oral Hygiene.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 主要终点
- Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1)
研究概览
简要总结
Brief Summary
The goal of this randomized clinical trial is to evaluate the clinical and antibacterial effects of a herbal toothpaste containing white mustard (Sinapis alba) extract in patients diagnosed with gingivitis. The main questions it aims to answer are:
Does the herbal toothpaste significantly reduce plaque index (PI), approximal plaque index (API), gingival index (GI), and bleeding on probing (BoP) compared to a placebo toothpaste?
Does the herbal toothpaste effectively reduce the bacterial loads of Streptococcus mutans and Lactobacillus spp. in saliva compared to a placebo?
Researchers will compare the effects of the herbal toothpaste to a placebo toothpaste to determine its efficacy in improving periodontal parameters and reducing bacterial levels.
Participants will:
Be randomly assigned to one of two groups: test group (herbal toothpaste) or control group (placebo toothpaste).
Use the assigned toothpaste twice daily for 4 weeks.
Undergo clinical evaluations at baseline (T0) and after 4 weeks (T1), including measurements of PI, API, GI, and BoP.
Provide saliva samples at T0 and T1 for microbiological analysis of Streptococcus mutans and Lactobacillus spp. bacterial loads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants were randomly assigned to two groups and blinded - Experimental vs placebo. They got toothpaste samples in identically marked white tubes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 65 years,
- •the presence of at least 20 teeth excluding third molars,
- •a diagnosis of gingivitis according to the 2017 World Workshop
- •non-smokers.
- •the motivation to take part in the study,
- •proper oral home hygiene
- •sign a consent agreement for the participation in the study
排除标准
- •patients aged <18
- •the presence of less than 20 teeth
- •severe systemic diseases and diseases that require regular systemic drugs (diabetes mellitus)
- •the use of systemic antibiotics during the last 3 months or local antiseptics that may affect biofilm formation (antibacterial mouth rinses containing chlorhexidine 4 weeks or less prior recruitment)
- •allergy to mustard or any other compound of experimental toothpaste
- •patients undergoing orthodontic treatment
- •women who were pregnant or breastfeeding.
研究组 & 干预措施
Experimental Group
Participants in this group receive a herbal toothpaste containing white mustard (Sinapis alba) extract.
The toothpaste is formulated with 0.5% white mustard extract, known for its antibacterial properties.
Participants are instructed to brush their teeth twice daily for 4 weeks using this toothpaste.
The primary goal is to evaluate its effect on plaque index (PI), approximal plaque index (API), gingival index (GI), bleeding on probing (BoP), and the bacterial loads of Streptococcus mutans and Lactobacillus spp.
干预措施: Toothpaste including mustard extract (Drug)
Control Group
Participants in this group receive a placebo toothpaste, which has the same base formulation as the experimental toothpaste but without white mustard extract.
They are also instructed to brush their teeth twice daily for 4 weeks using the assigned toothpaste.
This arm serves as a control group to compare the effects of the herbal toothpaste with a non-herbal alternative.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1)
时间窗: From start of intervention, 4 weeks to end of intervention and data collection.
Change in Plaque Index (PI) from Baseline (T0) to Week 4 (T1) Measured using the Silness and Loe Plaque Index (PI) Scale to assess plaque accumulation on tooth surfaces. Unit: Plaque score (0-3 scale). Time Frame: Baseline (T0) and Week 4 (T1).
Change in Bleeding on Probing (BoP) from Baseline (T0) to Week 4 (T1)
时间窗: From start of intervention, 4 weeks to end of intervention and data collection.
Change in Bleeding on Probing (BoP) from Baseline (T0) to Week 4 (T1) Measured using the Ainamo and Bay method, which evaluates gingival bleeding after gentle probing. Unit: Percentage of bleeding sites. Time Frame: Baseline (T0) and Week 4 (T1).
次要结局
- Change in Approximal Plaque Index (API) from Baseline (T0) to Week 4 (T1)(4 weeks)
- Change in Gingival Index (GI) from Baseline (T0) to Week 4 (T1)(4 weeks)
- Change in Salivary Bacterial Loads of Streptococcus mutans and Lactobacillus spp. from Baseline (T0) to Week 4 (T1)(4 weeks)