NCT06962956进行中（未招募）1 期
An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Number Bleeding Sites
研究概览
简要总结
This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide informed consent and receive a signed copy of the informed consent form;
- •Be between 25 - 65 years of age;
- •Have at least 16 gradable teeth;
- •Have a minimum of (approximately) 30% of bleeding sites and no more than two teeth with pockets deeper than 5mm or deemed acceptable by the Investigator/Designee (unhealthy test subjects only);
- •Have less than or equal to 3 bleeding sites and with all pockets less than or equal to 3mm deep (healthy test subjects only);
- •Agree to fast 12 hours prior to any visit with a blood collection;
- •Agree to not perform any oral hygiene for at least 12 hours prior to any visit with dental exams, saliva collection, and plaque collections;
- •Agree to refrain from eating or drinking, using medicated lozenges, breaths mints, and chewing gum at least 4 hours prior to this study visit (exception allowed: small sips of water up until 45 minutes prior to their appointment) for any visit with plaque collections;
- •Agree to refrain from use of any non-study oral hygiene products after the Product Distribution visit;
- •Agree to continue their current oral hygiene products and habits until the Product Distribution visit;
- •Agree to delay any elective dentistry, including dental prophylaxis outside of the study protocol, until the completion of the study;
- •Agree to all study restrictions for the duration of the study (medicines/supplements/vaccines- see restricted list);
- •Agree not to participate in any other oral care studies for the duration of this study;
- •Agree to return for all scheduled visits and to follow all study procedures; and
- •Be in good general health, as determined by the Investigator/Designee based on a review of their health history.
排除标准
- •Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
- •Active treatment for gingivitis, periodontitis, or caries;
- •Daily use of NSAID;
- •Having any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, peri/oral piercings, a pacemaker or other implanted device, unless deemed acceptable by the Investigator/Designee;
- •A condition requiring the need for antibiotic premedication prior to dental procedures;
- •Use of anti-inflammatory or anti-coagulant medications within 2 weeks of the Baseline visit, unless deemed acceptable by the Investigator/Designee;
- •Having had oral/gum surgery within the previous 2 months;
- •Smoking or vaping (regardless of content), use of smokeless tobacco, e-cigarettes, or nicotine patches);
- •Currently using recreational drugs;
- •Having been diagnosed with cardiovascular disease, diabetes (having an A1C ≥ 7), rheumatoid arthritis, liver disease, IBS, Crohn's Disease, Chronic Kidney Disease, or any type of autoimmune disease;
- •Having any gastrointestinal issues (e.g. diarrhea, vomiting) in the past week;
- •Use of statins or cholesterol lowering medication or supplements (e.g., Flax seeds, omega-3 fatty acids, Magnesium Oxide ≥250mg, Zyflamed, supplements containing berberine, golden thread, turmeric, CoQ10, or quercetin) for the duration of the study;
- •Use of antibiotics or having a dental prophylaxis in the last 4 weeks prior the baseline visit, unless deemed acceptable by the Investigator/Designee;
- •Receiving a flu shot or other vaccination in the last 4 weeks prior the baseline visit;
- •Inability to undergo any study procedures;
- •Currently undergoing treatment with GLP-1s antagonist;
- •Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; or
- •Having any condition or disease, as determined by the Investigator/Designee based on a review of the medical history which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
研究组 & 干预措施
Negative Control
Active Comparator
0.76% sodium monofluorophosphate
干预措施: 0.76% Sodium Monofluorophosphate Dentifrice (Drug)
Test
Active Comparator
0.454% stannous fluoride
干预措施: 0.454% Stannous Fluoride Dentifrice (Drug)
Positive Control
Active Comparator
0.454% stannous fluoride
干预措施: 0.454% Stannous Fluoride Dentifrice (Drug)
结局指标
主要结局
Number Bleeding Sites
时间窗: 4 months
Total number of bleeding sites
次要结局
未报告次要终点
研究者
研究点 (1)
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