Dental Erosion in Patients With Gastro-oesophageal Reflux

Suspended

• Conditions: Dental Erosion
• Interventions: Other: Collection of saliva samples; Other: Visual detection of BEWE-index

• Registration Number: NCT02775149
• Lead Sponsor: University of Göttingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Study Start: 2016-11-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reflux patients	Collection of saliva samples	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
Reflux patients	Visual detection of BEWE-index	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

Primary Outcome Measures

Name	Time	Method
Visual assessment of the BEWE-(basic erosive wear examination)-index	After removal of the probe (on second day)

Secondary Outcome Measures

Name	Time	Method
Determination of unstimulated and stimulated saliva flow rate (ml/min).	While wearing the probe at three time points over 24h: morning, noon, evening
Determination inorganic calcium and phosphate in saliva (mmol/L).	While wearing the probe at three time points over 24h: morning, noon, evening
Determination of saliva pH and buffer capacity (mol/L).	While wearing the probe at three time points over 24h: morning, noon, evening
Determination of total protein content in saliva (g/L).	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).	While wearing the probe at three time points over 24h: morning, noon, evening