Back to resultsIn Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole
Primary Purpose
Tooth Erosion
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Tooth Erosion focused on measuring dental erosion, OCT, proton pump inhibitor
Eligibility Criteria
Inclusion Criteria:
- Dental erosions with Lussi score greater than 1, diagnosed by dentist
- Provision of informed consent
- Male or female aged 18 or above years
- 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:
- Significant illness within 2 weeks of study begin as judged by investigator.
- Established or suspected non-reflux causes for dental erosions.
- Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
- Inability or unwillingness to give informed consent.
- Inability to attend all study.
- 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.
- Allergy to or other contraindication for treatment with esomeprazole.
- Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
- Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
- 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.
- Congenital dental defects.
- Ongoing pregnancy or breast-feeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
esomeprazole
placebo
Arm Description
Esomeprazole 20mg twice daily
Placebo tablet twice daily
Outcomes
Primary Outcome Measures
Dental erosions by OCT
Secondary Outcome Measures
OCT parameters
Full Information
NCT ID
NCT00564330
First Posted
November 26, 2007
Last Updated
August 25, 2014
Sponsor
Brain-Gut Research Group
Collaborators
Beckman Laser Institute University of California Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00564330
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brain-Gut Research Group
Collaborators
Beckman Laser Institute University of California Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Erosion
Keywords
dental erosion, OCT, proton pump inhibitor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esomeprazole
Arm Type
Active Comparator
Arm Description
Esomeprazole 20mg twice daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo bid
Primary Outcome Measure Information:
Title
Dental erosions by OCT
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
OCT parameters
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dental erosions with Lussi score greater than 1, diagnosed by dentist
Provision of informed consent
Male or female aged 18 or above years
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:
Significant illness within 2 weeks of study begin as judged by investigator.
Established or suspected non-reflux causes for dental erosions.
Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
Inability or unwillingness to give informed consent.
Inability to attend all study.
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.
Allergy to or other contraindication for treatment with esomeprazole.
Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
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.
Congenital dental defects.
Ongoing pregnancy or breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive H. Wilder-Smith, MD
Organizational Affiliation
Brain-Gut Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petra Wilder-Smith, Professor
Organizational Affiliation
Beckman and Laser Institute, University of California, Irvine, USA
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole
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