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

NCT ID: NCT00564330

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-05-31

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

Conditions

Tooth Erosion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

esomeprazole

Esomeprazole 20mg twice daily

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

20mg bid

placebo

Placebo tablet twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo bid

Interventions

Esomeprazole

20mg bid

Intervention Type: DRUG

Placebo

Placebo bid

Intervention Type: DRUG

Other Intervention Names

Nexium

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

Brain-Gut Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clive H. Wilder-Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Brain-Gut Research Group

Petra Wilder-Smith, Professor

Role: STUDY_DIRECTOR

Beckman and Laser Institute, University of California, Irvine, USA

Other Identifiers

D9612L00118

Identifier Type: -

Identifier Source: org_study_id