Dental Erosion in Patients With Gastro-oesophageal Reflux

NCT02775149 | Suspended

• 2 other identifiers: Erosion-Reflux2/11/15
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Erosion

Outcome Measures

Primary Outcomes (1)

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

  After removal of the probe (on second day)

Secondary Outcomes (5)

• Determination of unstimulated and stimulated saliva flow rate (ml/min).

  While wearing the probe at three time points over 24h: morning, noon, evening

• Determination of saliva pH and buffer capacity (mol/L).

  While wearing the probe at three time points over 24h: morning, noon, evening

• Determination of total protein content in saliva (g/L).

  While wearing the probe at three time points over 24h: morning, noon, evening

• Determination inorganic calcium and phosphate in saliva (mmol/L).

  While wearing the probe at three time points over 24h: morning, noon, evening

• 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

Study Arms (1)

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

Collection of saliva samples OTHER

Collection of saliva samples

Reflux patients

Visual detection of BEWE-index OTHER

Visual detection of BEWE-index

Reflux patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Exploratory study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Göttingen: lead

Related 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(Suppl 1):S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29.

  PMID: 18228057 BACKGROUND

• 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.

  PMID: 24993267 BACKGROUND

• 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.

  PMID: 15240067 BACKGROUND

• 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.

  PMID: 22004279 BACKGROUND

• 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.

  PMID: 22472533 BACKGROUND

• 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.

  PMID: 20696201 BACKGROUND

• 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.

  PMID: 25922678 BACKGROUND

• 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.

  PMID: 27022647 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples are obtained and retained for 10 years.

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Annette Wiegand, Prof. Dr. med. dent.

  Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. dent.

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 17, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share