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

Tooth Erosion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564330
• Other study ID #: D9612L00118
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 26, 2007
• Last updated: August 25, 2014
• Start date: November 2007
• Est. completion date: May 2008

Study information

• Verified date: August 2014
• Source: Brain-Gut Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tooth Erosion

Intervention

Drug:
• Esomeprazole
20mg bid
• Placebo
Placebo bid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brain-Gut Research Group	Beckman Laser Institute University of California Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental erosions by OCT		3 weeks	No
Secondary	OCT parameters		3 weeks	No