Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model

Procter and Gamble1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2021年3月1日最近更新: 2022年7月19日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 15
试验地点: 1
主要终点: Enamel Fluoride Uptake (EFU)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Double (Participant, Investigator)

盲法说明

Fifth leg of the study will not be randomized, participants will remain blinded but all will use the same product.

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

•Be between 18 and 85 years of age;
•Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
•Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
•Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
•Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;
•Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture;
•Be in good medical and dental health with no active caries or periodontal disease (NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1);
•Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).

排除标准

•Currently being pregnant, intending to become pregnant during the study period, or breast feeding;
•Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
•Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
•Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
•Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
•Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.