A Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste

Colgate Palmolive1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2023年3月8日最近更新: 2024年4月15日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Colgate Palmolive
入组人数: 100
试验地点: 1
主要终点: Measurement of total bacterial counts in saliva

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

This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.

研究设计

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

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male and female subjects, ages 18-70, inclusive.
•Subject is available during study duration and has no allergies to oral hygiene formulations.
•A minimum of 20 natural teeth with facial and lingual scorable surfaces.
•A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
•Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].

排除标准

•Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
•History of dental prophylaxis or treatments in the past month or during study duration.
•History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
•Subjects scheduled for medical procedures for the duration of the study.
•Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
•History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
•History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
•History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
•Oral soft tissue pathology.
•History of active or severe periodontal disease and loose teeth.
•Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
•Fixed or removable orthodontic appliance or removable partial dentures.
•Self-reported pregnancy or lactation.
•Subjects known to be an alcoholic, or a recovering alcoholic.
•History or current use of recreational drugs or other habit promoting products.
•Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
•Ability to refrain from oral hygiene for twelve (12) hours prior to scheduled visit.

研究组 & 干预措施

Group I

Active Comparator

toothpaste brushing 2/day for 2 minutes

干预措施: Colgate Dental Cream (Drug)

Group II

Experimental

toothpaste brushing 2/day for 2 minutes

干预措施: Stannous fluoride toothpaste (Drug)