The effect of toothpaste on tooth enamel to protect against erosion
Research type
Research Study
Full title
A Clinical Study to Measure the Anti-Erosion Properties of Two Dentifrices, 2015077.
IRAS ID
188135
Contact name
Nicola West
Contact email
Sponsor organisation
The Proctor & Gamble Company
Duration of Study in the UK
0 years, 3 months, 10 days
Research summary
The objective of this study is to compare the efficacy of two toothpastes to protect against enamel erosion following 10 days of use in subjects’ mouths.
Clinical Study Design
This will be a supervised study of approximately 36 healthy subjects who will be fitted with an appliance that fits in the roof of their mouth. The appliance will contain two human enamel samples that have been properly sterilized to meet human clinical testing standards. Subjects will be randomized to toothpaste treatment products across 4 study periods lasting 10 days each. Each subject will use each toothpaste treatment twice during the study.Each treatment day, subjects will brush their teeth in the morning using an assigned non-treatment toothpaste and toothbrush (at home). At the clinical site the subjects will collect their oral appliance to wear for approximately 6 hours. At the site, subjects will do supervised swishing with their assigned treatment toothpaste slurry (toothpaste swished around in their mouth) twice a day for 60 seconds. Subjects will also rinse their mouths with orange juice (acid challenge) four times each treatment day with their appliance in their mouth. Acid challenges will be done by swishing 25 ml orange juice in their mouth for one minute, spitting it out and repeating for a total of 10 swishes in each challenge. Subjects’ oral appliances will be placed in a moist pot for overnight storage
On Day 10 of each treatment period, the enamel samples will be removed from the subjects’ appliance. Protection against enamel tissue loss by the toothpastes will be assessed by surface profile readings (contact profilometry). New enamel samples will be inserted into the appliance for each treatment period.
Within two weeks of completing the last treatment period, subjects will attend a follow-up assessment, including a brief medical interview and oral examination.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0266
Date of REC Opinion
8 Oct 2015
REC opinion
Favourable Opinion