Gastro-oesophageal Reflux in Oligosymptomatic Patients Wi... | NCT02087345

Studies
Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

NCT02087345

Sponsor

Brain-Gut Research Group

Status

Unknown status

Last Update Posted

Mar 30, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Dental Erosion
Gastroesophageal Reflux

Interventions

Not provided

Countries

Switzerland

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2018Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Mar 10, 2014

First Submission Date that Met QC Criteria

Mar 12, 2014

First Posted Date

Mar 14, 2014Estimated

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

Mar 29, 2021

Last Update Posted Date

Mar 30, 2021Actual

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, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Given the high prevalence of dental erosions and the absence of any pH-impedance data or medical management guidelines for GERD-associated dental erosions, reflux characteristics will be characterized using questionnaires, endoscopy and esophageal pH-impedance testing, in successive patients dental erosions referred by dentists for evaluation of GERD. For assessment of the role of additional factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Label	Type	Description	Intervention Names
Dental erosions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The % of time with pH<4 and 5.5 during 24-hour pH-impedance		1 year

Secondary Outcomes

Measure	Description	Time Frame
The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance		1 year

Other Outcomes

Measure	Description	Time Frame
Association between dental erosion grades, gastric juice pepsin conc. and reflux episodes and % time with pH<4 and <5.5 during 24-hour pH-impedance	the % of reflux episodes reaching 15cm above the lower esophageal sphincter, concentration of pepsin and the tooth wear (BEWE) score: multivariate analysis with forward and backward elimination model to assess the best predicting variables.	1 year

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Successive male and female patients
Over 18 years of age presenting to the University of Bern Department of Dentistry and affiliated dentists
Dental erosions

Exclusion criteria:

Non-reflux causes of erosion
Reduced salivary flow and buffering capacity
History of bruxism, eating disorders, recurrent vomiting, severe obesity (BMI>35kg/m2) or past bariatric surgery
Dietary or abrasive causes for dental erosion

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

Successive male and female patients with dental erosions

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clive Wilder-Smith, MD	Contact	+41313123737		info@ggp.ch

Overall Officials

Name	Affiliation	Role
Clive Wilder-Smith, MD	Brain-Gut Reserach Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Group Practice	Recruiting	Bern			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29070010	Derived	Wilder-Smith CH, Materna A, Martig L, Lussi A. Longitudinal study of gastroesophageal reflux and erosive tooth wear. BMC Gastroenterol. 2017 Oct 25;17(1):113. doi: 10.1186/s12876-017-0670-1.

ID	Term
D014077	Tooth Erosion
D005764	Gastroesophageal Reflux

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