Dentin Sensitivity Clinical Trial
Official title:
A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.
Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride
This is a double blind parallel design, with respect to the clinical assessor and subject,
study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure
that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the
test site on six (6) occasions.
Subjects will be screened according to the inclusion and exclusion criteria. Suitable
subjects will be given a standard fluoride toothpaste and a toothbrush to use for the
following four to six weeks (Run-in Phase).
On completion of the run in phase, the subjects will have a baseline sensitivity and soft
tissue assessments conducted and randomised to product (visit 3).
Subjects will be randomly assigned to the test groups.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to
use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects
along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1
day) later.
At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue
assessments repeated.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to
use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along
with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects
will be instructed to brush their teeth as per the IFU for the following 2 weeks.
At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue
assessments repeated. Prior to leaving the study site, the subjects will be asked to brush
their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific
time and return to the study site the following day.
At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue
assessments repeated. On completion of the assessments, subjects will receive their
remuneration for the participating in the study.
;
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