Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)
研究概览
简要总结
This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
- •No current active caries or periodontal disease that may compromise the study or health of the subject.
- •All restorations in a good state of repair
- •Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
- •Willing to have their denture modified to accomodate enamel test specimens
- •Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
- •Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.
排除标准
- •Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
- •Current active caries or periodontal disease that may compromise the study or health of the subject.
研究组 & 干预措施
Fluoride Toothpaste 1
Fluoride toothpaste containing sodium fluoride (NaF)
干预措施: NaF (Drug)
Fluoride Toothpaste 2
Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
干预措施: NaF (Drug)
Fluoride Toothpaste 2
Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
干预措施: SnF (Drug)
Fluoride Toothpaste 3
Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
干预措施: NaF (Drug)
Fluoride Toothpaste 3
Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
干预措施: NaMFP (Drug)
Reference Dentifrice
Low fluoride toothpaste containing NaF
干预措施: NaF (Drug)
结局指标
主要结局
Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)
时间窗: Baseline to 14 days
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: \[(D-R)/(D-B)\]\*100.
次要结局
- %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)(Baseline to 14 days)
- Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)(Baseline to 14 days)