Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

NCT02087345 | Unknown

• 1 other identifier: BGRG-2414b
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Erosion; Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• The % of time with pH<4 and 5.5 during 24-hour pH-impedance

  1 year

Secondary Outcomes (1)

• The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance

  1 year

Other Outcomes (1)

• 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

Study Arms (1)

Dental erosions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Successive male and female patients with dental erosions

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brain-Gut Research Group: lead

Study Sites (1)

Gastroenterology Group Practice

Bern, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 29070010 DERIVED

Biospecimen

Retention: NONE RETAINED

gastric juice

MeSH Terms

Conditions

Tooth Erosion; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Clive Wilder-Smith, MD

  Brain-Gut Reserach Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clive Wilder-Smith, MD

CONTACT

+41313123737; info@ggp.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 14, 2014
• Study Start: December 15, 2018
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)