Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
研究概览
简要总结
The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study.
- •Aged 18 to 85 years.
- •Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •Has good general health (in the opinion of the investigator or medically qualified designee).
- •Currently living in the Indianapolis, Indiana area.
- •Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
- •Have no current active caries or periodontal disease and all restorations in a good state of repair.
- •Have a salivary flow rate in the range of normal values.
排除标准
- •Pregnant or breast feeding women.
- •Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
- •Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- •Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
- •Recent history (within the last year) of alcohol or other substance abuse.
研究组 & 干预措施
Test fluoride toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods
干预措施: Toothpaste containing 1150ppm F (Drug)
Fluoride free (0ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
干预措施: Toothpaste containing 0ppm F (Other)
Low dose fluoride (250ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
干预措施: Toothpaste containing 250ppm F (Drug)
Fluoride (1150ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
干预措施: Toothpaste containing 1150ppm F (Drug)
结局指标
主要结局
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
时间窗: 4 weeks
The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
次要结局
- Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments(4 weeks)
- Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments(4 weeks)
- Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments(4 weeks)