Clinical trial NCT02775149: Dental Erosion in Patients With Gastro-oesophageal Reflux
Official title: Dental Erosion in Patients With Gastro-oesophageal Reflux
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Dental Erosion
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exploratory study

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.


Eligibility 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

Primary outcomes:
measure: Visual assessment of the BEWE-(basic erosive wear examination)-index
timeFrame: After removal of the probe (on second day)
Secondary outcomes:
measure: Determination of unstimulated and stimulated saliva flow rate (ml/min).
timeFrame: While wearing the probe at three time points over 24h: morning, noon, evening
measure: Determination of saliva pH and buffer capacity (mol/L).
timeFrame: While wearing the probe at three time points over 24h: morning, noon, evening
measure: Determination of total protein content in saliva (g/L).
timeFrame: While wearing the probe at three time points over 24h: morning, noon, evening
measure: Determination inorganic calcium and phosphate in saliva (mmol/L).
timeFrame: While wearing the probe at three time points over 24h: morning, noon, evening
measure: Measurement of salivary enzyme activity: Protease, Kollagenase/Gelatinase, Pepsin, Trypsin, and Amylase (U/mL).
timeFrame: While wearing the probe at three time points over 24h: morning, noon, evening
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
name: Annette Wiegand, Prof. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.