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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02087345
Other study ID # BGRG-2414b
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2018
Est. completion date June 2023

Study information

Verified date March 2021
Source Brain-Gut Research Group
Contact Clive Wilder-Smith, MD
Phone +41313123737
Email info@ggp.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Gastroenterology Group Practice Bern

Sponsors (1)

Lead Sponsor Collaborator
Brain-Gut Research Group

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary The % of time with pH<4 and 5.5 during 24-hour pH-impedance 1 year
Secondary The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance 1 year
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