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

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

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 Overview

• Status: Completed
• Conditions: Tooth Erosion
• Intervention / Treatment: Drug: Placebo; Drug: Esomeprazole

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: esomeprazole; Esomeprazole 20mg twice daily	Drug: Esomeprazole; 20mg bid; Other Names: Nexium
Placebo Comparator: placebo; Placebo tablet twice daily	Drug: Placebo; Placebo bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dental erosions by OCT	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
OCT parameters	3 weeks

Collaborators and Investigators

• Sponsor: Brain-Gut Research Group
• Collaborators: Beckman Laser Institute University of California Irvine
• Investigators: Principal Investigator: Clive H. Wilder-Smith, MD, Brain-Gut Research Group; Study Director: Petra Wilder-Smith, Professor, Beckman and Laser Institute, University of California, Irvine, USA

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: November 26, 2007
• First Submitted That Met QC Criteria: November 26, 2007
• First Posted (Estimate): November 27, 2007

Study Record Updates

• Last Update Posted (Estimate): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 25, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: OCT; proton pump inhibitor; dental erosion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D9612L00118