In Vivo Quantification of Dental Demineralisation Using O... | NCT00564330

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

NCT00564330

Sponsor

Brain-Gut Research Group

Status

Completed

Last Update Posted

Aug 26, 2014Estimated

Enrollment

30Actual

Phase

Phase 1Phase 2

Conditions

Tooth Erosion

Interventions

Esomeprazole
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Nov 26, 2007

First Submission Date that Met QC Criteria

Nov 26, 2007

First Posted Date

Nov 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2014

Last Update Posted Date

Aug 26, 2014Estimated

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
esomeprazole	Active Comparator	Esomeprazole 20mg twice daily	Drug: Esomeprazole
placebo	Placebo Comparator	Placebo tablet twice daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole	Drug	20mg bid	esomeprazole	Nexium

Measure	Description	Time Frame
Dental erosions by OCT		3 weeks

Measure	Description	Time Frame
OCT parameters		3 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clive H. Wilder-Smith, MD	Brain-Gut Research Group	Principal Investigator
Petra Wilder-Smith, Professor	Beckman and Laser Institute, University of California, Irvine, USA	Study Director

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D057085	Tooth Wear

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds