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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

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Brain-Gut Research Group
ClinicalTrials.gov Identifier:
NCT00564330
First received: November 26, 2007
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Tooth Erosion
 Drug: Esomeprazole
Drug: Placebo
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brain-Gut Research Group:

Primary Outcome Measures:
  • Dental erosions by OCT [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OCT parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Esomperazole
 Drug: Esomeprazole
20mg bid
Other Name: Nexium
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo bid
Other Name: placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564330

Sponsors and Collaborators
Brain-Gut Research Group
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
  More Information

No publications provided

Responsible Party: Brain-Gut Research Group
ClinicalTrials.gov Identifier: NCT00564330     History of Changes
Other Study ID Numbers: D9612L00118
Study First Received: November 26, 2007
Last Updated: February 18, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Brain-Gut Research Group:
dental erosion
OCT
proton pump inhibitor
Effect of acid blockade on dental erosions and OCT parameters

Additional relevant MeSH terms:
Tooth Erosion
Tooth Wear
Tooth Diseases
Stomatognathic Diseases
Omeprazole
Proton Pump Inhibitors
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013