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

November 26, 2007
February 18, 2013
November 2007
April 2008   (final data collection date for primary outcome measure)
Dental erosions by OCT [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Dental erosions by OCT [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT00564330 on ClinicalTrials.gov Archive Site
OCT parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
OCT parameters [ Time Frame: 3 weeks ]
Not Provided
Not Provided
 
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
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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Tooth Erosion
  • Drug: Esomeprazole
    20mg bid
    Other Name: Nexium
  • Drug: Placebo
    Placebo bid
    Other Name: placebo
  • Active Comparator: 1
    Esomperazole
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00564330
D9612L00118
No
Brain-Gut Research Group
Brain-Gut Research Group
Beckman Laser Institute University of California Irvine
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
Brain-Gut Research Group
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP