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Dental Erosion in Patients With Gastro-oesophageal Reflux

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ClinicalTrials.gov Identifier: NCT02775149
Recruitment Status : Suspended (No participants)
First Posted : May 17, 2016
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen

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
Dental Erosion Other: Collection of saliva samples Other: Visual detection of BEWE-index

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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




Primary Outcome Measures :
  1. Visual assessment of the BEWE-(basic erosive wear examination)-index [ Time Frame: After removal of the probe (on second day) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Determination of saliva pH and buffer capacity (mol/L). [ Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening ]
  3. Determination of total protein content in saliva (g/L). [ Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening ]
  4. Determination inorganic calcium and phosphate in saliva (mmol/L). [ Time Frame: 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). [ Time Frame: While wearing the probe at three time points over 24h: morning, noon, evening ]

Biospecimen Retention:   Samples With DNA
Saliva samples are obtained and retained for 10 years.


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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:   Non-Probability Sample
Study Population
Exploratory study
Criteria

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

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): NCT02775149


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

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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 ( Other Identifier: Ethics Committee of the University Medical Center Göttingen )
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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