Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

NCT ID: NCT02087345

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-15

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Erosion Gastroesophageal Reflux

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dental erosions

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain-Gut Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clive Wilder-Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Brain-Gut Reserach Group

Locations

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Gastroenterology Group Practice

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Clive Wilder-Smith, MD

Role: CONTACT

+41313123737

Facility Contacts

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Clive Wilder-Smith, MD

Role: primary

+41313123737

References

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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.

Reference Type DERIVED
PMID: 29070010 (View on PubMed)

Other Identifiers

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BGRG-2414b

Identifier Type: -

Identifier Source: org_study_id

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