Clinical trial NCT00564330: In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tooth Erosion
Keywords: dental erosion
OCT
proton pump inhibitor
Lead sponsor: Brain-Gut Research Group
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: Dental erosions by OCT
timeFrame: 3 weeks
Secondary outcomes:
measure: OCT parameters
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Brain-Gut Research Group
name: Clive H. Wilder-Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman and Laser Institute, University of California, Irvine, USA
name: Petra Wilder-Smith, Professor
role: STUDY_DIRECTOR
References: