Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
研究概览
简要总结
This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •Age:Aged 18 to 80 years inclusive
- •Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
- •General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
- •Residency: Currently living in the Indianapolis, Indiana area
- •Dentures: a) Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). b) Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. c) All restorations in a good state of repair
- •Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).
排除标准
- •Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •Breast-feeding: Women who are breast-feeding
- •Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study
- •Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- •Fluoride: Prescribed or professionally recommended use of fluoride supplements or fluoride mouthrinse
- •Substance abuse: Recent history (within last year) of alcohol or other substance abuse
- •Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects
- •Personnel: a. A member of the site study staff who is directly working on the project or living in that staff's household. b. An employee of the sponsor c. Any employee of any toothpaste manufacturer or their spouse or family member
研究组 & 干预措施
Run in
Placebo
干预措施: Placebo (Drug)
Sodium Fluoride Toothpaste
Sodium fluoride toothpaste
干预措施: Sodium Fluoride Toothpaste (Drug)
Amine Fluoride Toothpaste
Amine Fluoride
干预措施: Amine Fluoride Toothpaste (Drug)
675ppmf toothpaste
Dose response
干预措施: 675 ppmf toothpaste (Drug)
Sodium monofluorophosphate/sodium fluoride Toothpaste
Sodium monofluorophosphate/sodium fluoride Toothpaste
干预措施: Sodium monofluorophosphate/Sodium Fluoride Toothpaste (Drug)
0 ppmf toothpaste
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
时间窗: Baseline to 14 days
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).
次要结局
- Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)(Baseline to 14 days)
- Change From Baseline in Enamel Fluoride Uptake Potential(Baseline to 14 days)