An exploratory study to investigate early dental erosion
Research type
Research Study
Full title
Study to Investigate the initial stages of enamel erosion in vivo 204739
IRAS ID
186096
Contact name
Nicola West
Contact email
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
Dental erosion is a condition that can lead to loss of dental hard tissue and is caused by the chemical influence of extrinsic and intrinsic acids without bacterial involvement. The very early stages of erosion are thought to involve demineralisation of the ultrastructural components of the enamel surface, and it is generally agreed that at this stage the condition is totally reversible since a mineral scaffold exists for remineralisation by saliva. The purpose of the study is to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. This is a single-centre, examiner-blind, randomised, two treatment, parallel group exploratory study in 30 healthy subjects with sound tooth enamel. Enamel surface topography will be assessed by dental impression following a supragingival prophylaxis, tooth brushing treatment with either a positive control fluoride toothpaste (Sensodyne Pronamel) or placebo (fluoride free) toothpaste, and a dietary acid challenge (lemon cordial). The study will comprise a Screening visit, a Baseline visit (Day 1) consisting of dental prophylaxis, 1 treatment, one dental impression and saliva donation to measure saliva buffering capacity, and a Treatment visit (Day 2) consisting of 10 procedures (1 treatment, 1 dietary challenge, 5 impressions and 2 saliva donations). The Baseline visit and Treatment visits will occur over 2 consecutive days. The Baseline visit will occur between 0 and 14 days of the Screening visit, if these are not combined.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0208
Date of REC Opinion
17 Aug 2015
REC opinion
Favourable Opinion