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SuspendedNCT02775149Updated Nov 6, 2020

Dental Erosion in Patients With Gastro-oesophageal Reflux

An observational study in Dental Erosion, sponsored by University of Göttingen. Suspended. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by University of Göttingen · Observational

Why this study was suspended
No participants
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Dental Erosion

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In context

Tooth Erosion

47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 13 observational studies indexed under Tooth Erosion.

Browse Tooth Erosion studies →

Lead sponsor

University of Göttingen is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Exploratory study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 · Other: Visual detection of BEWE-index

Interventions

  • OtherCollection of saliva samples

    Collection of saliva samples

  • OtherVisual detection of BEWE-index

    Visual detection of BEWE-index

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What researchers measure

Primary outcomes

  1. Visual assessment of the BEWE-(basic erosive wear examination)-index

    Time frame: After removal of the probe (on second day)

Secondary outcomes

  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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bartlett D, Ganss C, Lussi A. Basic Erosive Wear Examination (BEWE): a new scoring system for scientific and clinical needs. Clin Oral Investig. 2008 Mar;12 Suppl 1(Suppl 1):S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29. PubMed 18228057 ↗
  • Hara AT, Zero DT. The potential of saliva in protecting against dental erosion. Monogr Oral Sci. 2014;25:197-205. doi: 10.1159/000360372. Epub 2014 Jun 26. PubMed 24993267 ↗
  • Moazzez R, Bartlett D, Anggiansah A. Dental erosion, gastro-oesophageal reflux disease and saliva: how are they related? J Dent. 2004 Aug;32(6):489-94. doi: 10.1016/j.jdent.2004.03.004. PubMed 15240067 ↗
  • Ranjitkar S, Smales RJ, Kaidonis JA. Oral manifestations of gastroesophageal reflux disease. J Gastroenterol Hepatol. 2012 Jan;27(1):21-7. doi: 10.1111/j.1440-1746.2011.06945.x. PubMed 22004279 ↗
  • Schlueter N, Ganss C, Potschke S, Klimek J, Hannig C. Enzyme activities in the oral fluids of patients suffering from bulimia: a controlled clinical trial. Caries Res. 2012;46(2):130-9. doi: 10.1159/000337105. Epub 2012 Apr 3. PubMed 22472533 ↗
  • Wang GR, Zhang H, Wang ZG, Jiang GS, Guo CH. Relationship between dental erosion and respiratory symptoms in patients with gastro-oesophageal reflux disease. J Dent. 2010 Nov;38(11):892-8. doi: 10.1016/j.jdent.2010.08.001. Epub 2010 Aug 7. PubMed 20696201 ↗
  • Wilder-Smith CH, Materna A, Martig L, Lussi A. Gastro-oesophageal reflux is common in oligosymptomatic patients with dental erosion: A pH-impedance and endoscopic study. United European Gastroenterol J. 2015 Apr;3(2):174-81. doi: 10.1177/2050640614550852. PubMed 25922678 ↗
  • Kanzow P, Wegehaupt FJ, Attin T, Wiegand A. Etiology and pathogenesis of dental erosion. Quintessence Int. 2016 Apr;47(4):275-8. doi: 10.3290/j.qi.a35625. PubMed 27022647 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02775149
Lead sponsor
University of Göttingen
Responsible party
Philipp Kanzow, Dr. med. dent., Dr. rer. medic. (Dr. med. dent., University Medical Center Goettingen) — Principal investigator
First posted
May 17, 2016
Start date
Nov 1, 2016
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Nov 6, 2020

Study contacts

Annette Wiegand, Prof. Dr. med. dent.
principal investigator · Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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