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
- 57
- 试验地点
- 1
- 主要终点
- Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
研究概览
简要总结
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
详细描述
In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).
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 78 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 between 18 and 80 years.
- •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 relevant abnormalities of medical history or physical examination.
- •Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons
- •Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side. b) Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
- •Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and 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 milliliter (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.
- •Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- •Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study.
- •Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
- •Personnel:a) A member of the site study staff living in same 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
NaF toothpaste(1450 ppmF)
Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient.
干预措施: NaF (Drug)
NaF toothpaste (1400 ppmF)
Study toothpaste containing 1400 ppm F as NaF
干预措施: NaF (Drug)
NaMFP/NaF toothpaste (1450 ppmF)
Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF
干预措施: NaF (Drug)
NaMFP/NaF toothpaste (1450 ppmF)
Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF
干预措施: NaMFP (Drug)
NaF toothpaste (675 ppmF)
Study toothpaste containing 675 ppm F as NaF
干预措施: NaF (Drug)
Placebo toothpaste (0 ppmF)
Fluoride free placebo toothpaste (0 ppm F)
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
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 SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.
次要结局
- Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)(Baseline to 14 days)
- Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)(Baseline to 14 days)
- Enamel Fluoride Uptake (Demineralized Specimens)(Baseline to 14 days)
- Enamel Fluoride Uptake (Sound Enamel Specimens)(Baseline to 14 days)