Efficacy of Three Toothpastes Using an in Situ Caries Model
Status:
Completed
Trial end date:
2016-08-11
Target enrollment:
Participant gender:
Summary
This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period
crossover, incomplete block design, in situ caries study in healthy adults who wear a
removable bilateral mandibular partial denture. The denture will be modified to accommodate 4
gauze-covered specimens of human dental enamel (4x3mm) that have been previously
demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type
will be used with each participant). After 14 days of twice daily product use off-site, the 2
S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion
specimens removed at the study site after a further 14 days of product use. To determine the
remineralization ability of the treatments, all specimens will be analyzed by transverse
microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally
analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by
quantitative light fluorescence (QLF).