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Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

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ClinicalTrials.gov Identifier: NCT02087345
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : March 30, 2021
Information provided by (Responsible Party):
Brain-Gut Research Group

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.

Condition or disease
Dental Erosion Gastroesophageal Reflux

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Dental erosions

Primary Outcome Measures :
  1. The % of time with pH<4 and 5.5 during 24-hour pH-impedance [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance [ Time Frame: 1 year ]

Other Outcome Measures:
  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 [ Time Frame: 1 year ]
    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.

Biospecimen Retention:   None Retained
gastric juice

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Successive male and female patients with dental erosions

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087345

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Contact: Clive Wilder-Smith, MD +41313123737 info@ggp.ch

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Gastroenterology Group Practice Recruiting
Bern, Switzerland
Contact: Clive Wilder-Smith, MD    +41313123737    info@ggp.ch   
Principal Investigator: Clive Wilder-Smith, MD         
Sponsors and Collaborators
Brain-Gut Research Group
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Principal Investigator: Clive Wilder-Smith, MD Brain-Gut Reserach Group
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brain-Gut Research Group
ClinicalTrials.gov Identifier: NCT02087345    
Other Study ID Numbers: BGRG-2414b
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Tooth Erosion
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tooth Wear
Tooth Diseases
Stomatognathic Diseases