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Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02087345
Enrollment
500
Registered
2014-03-14
Start date
2018-12-15
Completion date
2023-06-30
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Erosion, Gastroesophageal Reflux

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.

Interventions

None listed

Sponsors

Brain-Gut Research Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The % of time with pH<4 and 5.5 during 24-hour pH-impedance1 year

Secondary

MeasureTime frame
The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance1 year

Other

MeasureTime frameDescription
Association between dental erosion grades, gastric juice pepsin conc. and reflux episodes and % time with pH<4 and <5.5 during 24-hour pH-impedance1 yearthe % 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.

Countries

Switzerland

Contacts

Primary ContactClive Wilder-Smith, MD
info@ggp.ch+41313123737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026