Dental Erosion in Patients With Gastro-oesophageal Reflux

Dental Erosion Clinical Trial

Official title:

Dental Erosion in Patients With Gastro-oesophageal Reflux

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02775149
• Other study ID #: Erosion-Reflux
• Secondary ID: 2/11/15
• Status: Suspended
• Start date: November 1, 2016
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Erosion
• Gastroesophageal Reflux
• Tooth Erosion

Intervention

Other:
• Collection of saliva samples
Collection of saliva samples
• Visual detection of BEWE-index
Visual detection of BEWE-index

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Göttingen

References & Publications (8)

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:S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Schlueter N, Ganss C, Pötschke 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of the BEWE-(basic erosive wear examination)-index		After removal of the probe (on second day)
Secondary	Determination of unstimulated and stimulated saliva flow rate (ml/min).		While wearing the probe at three time points over 24h: morning, noon, evening
Secondary	Determination of saliva pH and buffer capacity (mol/L).		While wearing the probe at three time points over 24h: morning, noon, evening
Secondary	Determination of total protein content in saliva (g/L).		While wearing the probe at three time points over 24h: morning, noon, evening
Secondary	Determination inorganic calcium and phosphate in saliva (mmol/L).		While wearing the probe at three time points over 24h: morning, noon, evening
Secondary	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