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

Phase 1

Completed

• Conditions: Tooth Erosion
• Interventions: Drug: Esomeprazole; Drug: Placebo

• Registration Number: NCT00564330
• Lead Sponsor: Brain-Gut Research Group

Brief 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

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-27
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Dental erosions with Lussi score greater than 1, diagnosed by dentist
2. Provision of informed consent
3. Male or female aged 18 or above years
4. 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

1. Significant illness within 2 weeks of study begin as judged by investigator.
2. Established or suspected non-reflux causes for dental erosions.
3. Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
4. Inability or unwillingness to give informed consent.
5. Inability to attend all study.
6. 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.
7. Allergy to or other contraindication for treatment with esomeprazole.
8. Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
9. Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
10. 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.
11. Congenital dental defects.
12. Ongoing pregnancy or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esomeprazole	Esomeprazole	Esomeprazole 20mg twice daily
placebo	Placebo	Placebo tablet twice daily

Primary Outcome Measures

Name	Time	Method
Dental erosions by OCT	3 weeks

Secondary Outcome Measures

Name	Time	Method
OCT parameters	3 weeks