Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Microhardness change
研究概览
简要总结
Clinical study to evaluate the anti-cavity efficacy of three dentifrices using an intra-oral enamel Demineralization - Remineralization In-Situ Model. This is a Phase III, single-center, triple-blind with a crossover design. It involves 36 participants aged between 18 and 70, randomized into 3 different groups + a washout group, and spans 6 weeks.
详细描述
This clinical study aims to evaluate the anti-cavity efficacy of dentifrices using an intra-oral enamel demineralization-remineralization in-situ model. It is a Phase III, randomized, triple-blind, crossover study involving 36 participants aged 18 to 70. Participants will use an intra-oral appliance with a steel mesh holding bovine enamel blocks, properly disinfected before using. Participants will be divided into three groups of treatment: one using a fluoride-free toothpaste with a chalk base and herbal ingredients, another using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base, and a negative control group using a fluoride-free toothpaste in a PCC/RNCC base. Each participant will receive a soft-bristle toothbrush and will be instructed to brush twice daily for 6 weeks. Additionally, between the treatment phases (5 days), 9-day washout phases will occur, during which participants will use a fluoride-free toothpaste in a PCC/RNCC base. Subjects will undergo baseline visit, visit 2 - washout I (9 days), visit 3 - treatment phase I (5 days), visit 4- washout II, visit 5- treatment phase II, visit 6 - washout III, visit 7 - treatment phase III, visit 8 - final visit. The primary outcome will be enamel microhardness, measured before and after treatment, to assess changes in microhardness. The expected outcome is the confirmation of the alternative hypothesis, which predicts a reduction in the percentage of mineral loss from the surface of bovine enamel after using dentifrices containing 1000 ppm MFP with 1.5% arginine or herbal ingredients for five days each, compared to the control group. The percentage of mineral loss on the tooth surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization. A two factor ANCOVA using the baseline as the covariate will be conducted to determine if a significant treatment effect exists. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In this clinical trial, masking involves several key roles to ensure unbiased results. The Participant, Care Provider, Investigator, and Outcomes Assessor are all masked in this triple-blind study. This means that the participants do not know which group they have been assigned to, the care providers administering the treatments are unaware of the specific products being used by each participant, the investigators conducting the study do not know the group assignments, and the outcomes assessors evaluating the results are blind to the treatment allocations. This comprehensive masking approach is designed to minimize any potential biases and maintain the integrity of the study results.
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
- •Males and females, between 18-70 years of age (inclusive);
- •Informed Consent Form signed and availability for the duration of the study;
- •Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- •Willingness to provide information related to their medical history;
- •Minimum of 20 uncrowned permanent natural teeth (excluding third molars); Normal salivary flow;
- •Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.
排除标准
- •Oral pathology, chronic disease, or a history of allergy to testing products;
- •Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- •Subject participating in any other clinical study;
- •Subject pregnant or breastfeeding;
- •Subject allergic to oral care products, personal care consumer products, or their ingredients;
- •Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
- •A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- •Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm
- •Five or more decayed, untreated dental sites (cavities);
- •Current smokers and subjects with a history of alcohol or drug abuse;
- •Dental work prevents wearing of the appliance or a reported need to wear a night guard.
研究组 & 干预措施
Fluoride toothpaste
Subjects will brush using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base and a soft bristle toothbrush
干预措施: Fluoride Toothpaste (Drug)
Fluoride toothpaste
Subjects will brush using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base and a soft bristle toothbrush
干预措施: Toothbrush (Device)
Fluoride free toothpaste in a chalk base
Subjects will brush using a fluoride free toothpaste in a chalk base with herbal ingredients and a soft bristle toothbrush
干预措施: Fluoride free toothpaste in a chalk base (Drug)
Fluoride free toothpaste in a chalk base
Subjects will brush using a fluoride free toothpaste in a chalk base with herbal ingredients and a soft bristle toothbrush
干预措施: Toothbrush (Device)
Fluoride free toothpaste in a PCC/RNCC base
This is a negative control group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush
干预措施: Fluoride free toothpaste in a PCC/RNCC base (Drug)
Fluoride free toothpaste in a PCC/RNCC base
This is a negative control group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush
干预措施: Toothbrush (Device)
Washout
This is a washout group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush for 9 days, between the treatment phases
干预措施: Fluoride free toothpaste in a PCC/RNCC base (Drug)
Washout
This is a washout group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush for 9 days, between the treatment phases
干预措施: Toothbrush (Device)
结局指标
主要结局
Microhardness change
时间窗: 6 weeks
The primary measured response will be a change in indentation length in the intra-oral appliance before and after treatment for microhardness. The indentation length will be used to calculate a hardness value. The percentage of mineral loss on the bovine tooth enamel surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization.
次要结局
未报告次要终点