Dental Erosion in Patients With Gastro-oesophageal Reflux

November 4, 2020 updated by: Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University of Göttingen

Not only caries but also exposure to acids can lead to loss of tooth structure. This acid-related tooth structure loss is defined as dental erosion.

A relationship between dental erosion and occurence of reflux disease was shown in numerous studies. On the one hand, patients with dental erosions frequently show reflux disease. On the other hand, many - but not all - reflux patients show dental erosions. It is believed that certain salivary parameters might explain, why not all reflux patients alike are affected of dental erosions.

The aim of this study is to analyze the relationship and the extent of occurrence of dental erosions and reflux symptoms, including investigation of certain salivary parameters.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Exploratory study

Description

Inclusion Criteria:

  • Patients who are treated at the Clinic for Gastroenterology and Gastrointestinal Oncology and have a 24-hours pH monitoring or impedance measurement performed for medical reasons

Exclusion Criteria:

  • Inability to give written consent
  • Age <18 years
  • Intake of proton pump inhibitors (PPIs) if they are not discontinued at least one week before study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Reflux patients
Patients who are treated at the Clinic for Gastroenterology and Gastrointestinal Oncology and have a 24-hours pH monitoring or impedance measurement performed for medical reasons
Other: Collection of saliva samples
Collection of saliva samples
Other: Visual detection of BEWE-index
Visual detection of BEWE-index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual assessment of the BEWE-(basic erosive wear examination)-index
Time Frame: After removal of the probe (on second day)
After removal of the probe (on second day)

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of unstimulated and stimulated saliva flow rate (ml/min).
Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening
While wearing the probe at three time points over 24h: morning, noon, evening
Determination of saliva pH and buffer capacity (mol/L).
Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening
While wearing the probe at three time points over 24h: morning, noon, evening
Determination of total protein content in saliva (g/L).
Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening
While wearing the probe at three time points over 24h: morning, noon, evening
Determination inorganic calcium and phosphate in saliva (mmol/L).
Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening
While wearing the probe at three time points over 24h: morning, noon, evening
Measurement of salivary enzyme activity: Protease, Kollagenase/Gelatinase, Pepsin, Trypsin, and Amylase (U/mL).
Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening
While wearing the probe at three time points over 24h: morning, noon, evening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erosion-Reflux
  • 2/11/15 (Other Identifier: Ethics Committee of the University Medical Center Göttingen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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