Dental Erosion in Patients With Gastro-oesophageal Reflux

Sponsor
University of Göttingen (Other)
Overall Status
Suspended
CT.gov ID
NCT02775149
Collaborator
(none)
30
61

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Collection of saliva samples
  • Other: Visual detection of BEWE-index

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Dental Erosion in Patients With Gastro-oesophageal Reflux
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Visual assessment of the BEWE-(basic erosive wear examination)-index [After removal of the probe (on second day)]

Secondary Outcome Measures

  1. Determination of unstimulated and stimulated saliva flow rate (ml/min). [While wearing the probe at three time points over 24h: morning, noon, evening]

  2. Determination of saliva pH and buffer capacity (mol/L). [While wearing the probe at three time points over 24h: morning, noon, evening]

  3. Determination of total protein content in saliva (g/L). [While wearing the probe at three time points over 24h: morning, noon, evening]

  4. Determination inorganic calcium and phosphate in saliva (mmol/L). [While wearing the probe at three time points over 24h: morning, noon, evening]

  5. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Göttingen

Investigators

  • Principal Investigator: Annette Wiegand, Prof. Dr. med. dent., Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Dr. med. dent., University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT02775149
Other Study ID Numbers:
  • Erosion-Reflux
  • 2/11/15
First Posted:
May 17, 2016
Last Update Posted:
Nov 6, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 6, 2020