A Phase 1/2 interventional study of Esomeprazole and Placebo in Tooth Erosion, sponsored by Brain-Gut Research Group. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-26.
Sponsored by Brain-Gut Research Group · Phase 1/2, Interventional, and Diagnostic
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.
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
Exclusion Criteria:
Esomeprazole 20mg twice daily
Drug: Esomeprazole
Placebo tablet twice daily
Drug: Placebo
20mg bid
Also known as: Nexium
Placebo bid
Dental erosions by OCT
Time frame: 3 weeks
OCT parameters
Time frame: 3 weeks
No study locations are listed for this record.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Brain-Gut Research Group