NCT05330793已完成不适用
Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
USANA Health Sciences2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Gingival Index
研究概览
简要总结
- Randomized double-blind, placebo-controlled trial on the effects of an oral probiotic intervention with or without a novel ADP-1 toothpaste Objective
- Determine the safety and effectiveness of oral probiotic intervention with or without a novel toothpaste and compare with placebo
详细描述
Hypotheses:
- Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges.
- Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than subjects using oral probiotics and regular toothpaste, and subjects using regular toothpaste and placebo lozenges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ages 18 to 65 years old
- •Fluent in English
- •Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)
- •Bleeding on probing on 30%+ areas
- •Able to perform oral hygiene adequately after formal instructions
- •Able to understand and comply with study procedure
- •Able to provide written informed consent
- •Able to come to Roseman Dental Clinics in South Jordan for a 90-minute pre-screening to determine eligibility
- •Able to complete five (90-minute) clinic visits in 2-week intervals
排除标准
- •• Probing depths less than 3mm
- •Breastfeeding, pregnant or trying to become pregnant
- •Currently taking or have taken any of the following within 30 days of enrollment:
- •Oral probiotics
- •Antibiotic medications
- •Antifungal medications (e.g., nystatin, clotrimazole, ketoconazole, griseofulvin)
- •Antiseptic medications
- •Immunosuppressant and/or chemotherapeutic medications
- •Medications that could affect gum response measurement (e.g., calcium channel blockers, cyclosporin, anti-seizures like phenytoin and related drugs, anti-inflammatory agents)
- •Frequent alcohol consumption (> 2 drinks per day, or > 8 per week for women, or > 15 per week for men)
- •Use of marijuana (which can cause dry mouth or other conditions) or recreational drugs
- •Use of tobacco products including chewing tobacco and all types of cigarettes (e-cigarettes)
- •Known allergy to any product ingredient (ingredient list provided by USANA)
结局指标
主要结局
Gingival Index
时间窗: 8 weeks
• Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Plaque Index
时间窗: 8 weeks
• Plaque index is used as a method of recording the presence of plaque on individual tooth surfaces. These surfaces are mesial, distal, buccal and lingual.
次要结局
- Intraoral Imaging(8 weeks)
- Microbial Community Analysis(8 weeks)
- Halitosis(8 weeks)
- SAQ(8 weeks)
研究者
研究点 (2)
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