Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087345
• Other study ID #: BGRG-2414b
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Dental Erosion
• Gastroesophageal Reflux
• Tooth Erosion

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