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

NCT00564330 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-08-26

No results posted yet for this study

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.

Conditions

  • Tooth Erosion

Interventions

DRUG

Esomeprazole

20mg bid

DRUG

Placebo

Placebo bid

Sponsors & Collaborators

  • Beckman Laser Institute University of California Irvine

    collaborator OTHER

  • Brain-Gut Research Group

    lead OTHER

Principal Investigators

  • Clive H. Wilder-Smith, MD · Brain-Gut Research Group

  • Petra Wilder-Smith, Professor · Beckman and Laser Institute, University of California, Irvine, USA

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-04-30
Completion
2008-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564330 on ClinicalTrials.gov