Evaluation of calculus formation after 12 weeks toothpaste/gel use.
Research type
Research Study
Full title
A Study to Measure Calculus formation after 12 weeks use of a calcium silicate based toothpaste and gel compared to a conventional toothpaste.
IRAS ID
161597
Contact name
Nicola West
Contact email
Sponsor organisation
Unilever
Research summary
This is a 2 treatment group parallel, single blind (to the person carrying out the assessments) study. Up to 225 subjects will be recruited so that a minimum of 210 subjects are enrolled on to the study to ensure that at least 105 subjects are randomised to each test product.
At the screening visit, subjects will provide written informed consent and will be screened for eligibility. If the subject fulfils the inclusion/exclusion criteria, then their levels of supra gingival calculus on 6 eligible lower anterior teeth will be measured. The subjects will then be given a full mouth prophylaxis to remove supra and sub gingival calculus formation. After the completion of the prophylaxis a Clinician will ensure that no supra or sub gingival calculus deposits remain on the lower anterior teeth. Subjects will then will then be randomised and allocated a test product to use for the following 12 weeks as instructed by the study staff. Subjects will then return to the study site after approximately 6 and 12 weeks of product use to have levels of supra gingival calculus on their lower anterior teeth assessed and measured.
Supra gingival calculus will be measured using the Volpe-Manhold index. In addition calculus will be scored by Ipad planimetry (C-Calc) at all assessment visits. Photographs will also be taken of the lingual surfaces of the lower anterior teeth for observation.
At screening and after 12 weeks of product use, subjects will be asked to provide approximately 2mls of unstimulated saliva following calculus assessments. The concentration of calcium will be measured in the saliva.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1060
Date of REC Opinion
11 Sep 2014
REC opinion
Favourable Opinion