CSSP Technology for Hypersensitivity Pain Relief V1
Research type
Research Study
Full 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. ORL-SEN-2530.
IRAS ID
220711
Contact name
Julie Nicholson
Contact email
Sponsor organisation
Unilever Research and Development Port Sunlight
Clinicaltrials.gov Identifier
MHRA submission, IRAS ID 220711
Duration of Study in the UK
0 years, 9 months, 16 days
Research summary
A novel technology toothpaste (Advanced Toothpaste Experimental) has been developed by Unilever which is based on the combination of calcium silicate and sodium phosphate salts. The technology augments the natural mineralisation processes of human saliva by providing additional calcium and phosphate, nucleating hydroxyapatite (HAP) formation and leading to overall remineralisation of tooth enamel mineral (HAP). \nIn-vitro studies to confirm the mode of action have indicated that the toothpaste can also help to block open dentine tubules and potentially protect dentine from acid challenges, which could contribute to possible anti-hypersensitivity benefits1. The results of an in-vitro study also indicate that the level of tubule occlusion increases over time. The technology has been formulated into a toothpaste containing calcium silicate, sodium phosphate salts (Monosodium Phosphate and Trisodium Phosphate).\n\nThe proposed study is being conducted to investigate the anti-hypersensitivity benefits of the toothpaste as supported by the results of the in-vitro study.\n\nThe clinical study is being conducted to support the following medical device claim:\n•\treduction of pain associated with dentinal hypersensitivity\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0007
Date of REC Opinion
10 Feb 2017
REC opinion
Further Information Favourable Opinion