In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole

Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (OCT) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks.

The primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition.

Secondary objectives are:

To compare standardised visual scoring with OCT quantification of reflux damage at the different time points on different teeth.

To assess sex differences in OCT- quantified dental tissue loss

Inclusion criteria

• Dental erosions with Lussi score greater than 1, diagnosed by dentist
• Provision of informed consent
• Male or female aged 18 or above years
• GORD defined by time with pH<4 greater than 3.5% during 24 hours demonstrated by 24h-hour pH-metry in the last 6 months before the start of the study

Exclusion criteria

• Significant illness within 2 weeks of study begin as judged by investigator.
• Established or suspected non-reflux causes for dental erosions.
• Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
• Inability or unwillingness to give informed consent.
• Inability to attend all study.
• New dental treatment (including dental products) may not be begun from 2 weeks before study begin until the end of the study, except usual dental hygiene with usual toothpaste.
• Allergy to or other contraindication for treatment with esomeprazole.
• Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
• Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
• Change or planned change in normal medication or use of herbal, mineral, vitamin preparations within 2 weeks of study start and until the end of the study.
• Congenital dental defects.
• Ongoing pregnancy or breast-feeding.