Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

Sponsor

Brain-Gut Research Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT02087345

Collaborator

(none)

500

Enrollment

Location

53.5

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Erosion Gastroesophageal Reflux

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 15, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Dental erosions

Outcome Measures

Primary Outcome Measures

The % of time with pH<4 and 5.5 during 24-hour pH-impedance [1 year]

Secondary Outcome Measures

The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance [1 year]

Other Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Group Practice	Bern		Switzerland

Sponsors and Collaborators

Brain-Gut Research Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brain-Gut Research Group

ClinicalTrials.gov Identifier:

NCT02087345

Other Study ID Numbers:

BGRG-2414b

First Posted:

Mar 14, 2014

Last Update Posted:

Mar 30, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Tooth Erosion

Study Results

No Results Posted as of Mar 30, 2021