NCT00564330

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

In Vivo Quantification of Dental Demineralisation Using Optical Coherence Tomography Before and After Double-blind, Randomised Treatment With Esomeprazole or Placebo of Patients With Dental Erosions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Brain-Gut Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Tooth Erosion

Interventions

Type	Name	Description
DRUG	Esomeprazole	20mg bid
DRUG	Placebo	Placebo bid

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-04-01
• Completion: 2008-05-01
• First posted: 2007-11-27
• Last updated: 2014-08-26