Evaluation of Dentifrice Foam
Research type
Research Study
Full title
Evaluation of Dentifrice Foam
IRAS ID
112749
Contact name
Alice Bordas
Contact email
Research summary
The aim of the study is to test an experimental fluoride containing toothpaste by assessing firstly the quantity of toothpaste foam in the mouth and its distribution on the surface of the tongue after toothbrushing, and secondly the effects of the test toothpaste on the bacteria present in saliva.
The distribution of the foam over the tongue will be assessed by a dental professional from pictures taken of the tongue after brushing.
The quantity of foam will be measured by asking the subjects to expectorate (spit) into a dosing cup after brushing. A sample of this expectorate will be taken to assess the number of bubbles in the foam using a specialized microscope.
The bacteria in the saliva will be assessed by asking the subject to provide a pre-treatment saliva sample followed by two post-brushing saliva samples, at 15 and 30 minutes respectively.The active ingredient in all the test toothpastes is sodium fluoride (927ppm fluoride)and is in compliance with the regulatory guidelines related to fluoride for products marketed in the EU.
22 subjects meeting the entry criteria will be randomised into the study. The total duration of the study will be approximately 4 weeks in total (and maximum 10 days for each subject, comprising of one screening and a single treatment visits. To complete the study a subject will attend the site on 2 occasions.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0312
Date of REC Opinion
2 Aug 2013
REC opinion
Further Information Favourable Opinion