Impact of chewing gum with CPP-ACP on tooth mineralisation in situ
Research type
Research Study
Full title
Impact of chewing gum containing CPP-ACP on tooth mineralisation, using an in situ appliance in healthy subjects
IRAS ID
234067
Contact name
Susan M. Higham
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 3 days
Research summary
The purpose of this study is to assess the effect of sugar-free chewing gum containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on human enamel demineralisation in situ using a removable appliance. CPP-ACP is part of Recaldent™ and is derived from the milk protein, casein. Research has shown that this milk derivatives have a tooth protective effect. This activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP).
In a two leg crossover double-blind controlled study 14 healthy volunteers aged 18-55 will carry intra-oral dental appliance with slabs of human enamel bearing demineralised lesions while consuming one of two sugar-free chewing gums 5 times a day for 20 minutes and for the period of two weeks per leg. The appliance should be worn 24 h a day by the subjects, including during eating and drinking (but the appliances should be removed for daily oral hygiene procedure and cleaning of the appliance itself). Sugar-free chewing gum without CPP-ACP will be used as a negative control. Each appliance will contain two types of the demineralised enamel blocks: three blocks will contain shallow subsurface lesions (Carbopol method) and the other three reflecting deeper subsurface lesions (hydroxy-ethyl cellulose method). Both types of lesions have been the subject of oral research interest, as both shallow and deep lesions are involved in caries genesis. The degree of mineral changes in the enamel slabs will be measured at the end of each leg in the laboratory using transverse microradiography.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0740
Date of REC Opinion
15 Jan 2020
REC opinion
Further Information Favourable Opinion