Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

March 29, 2021 updated by: Brain-Gut Research Group

Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland
        • Recruiting
        • Gastroenterology Group Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Successive male and female patients with dental erosions

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dental erosions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brain-Gut Research Group

Investigators

  • Principal Investigator: Clive Wilder-Smith, MD, Brain-Gut Reserach Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGRG-2414b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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