Dental ErosionNCT02775149
Dental Erosion in Patients With Gastro-oesophageal Reflux
An observational study of Dental Erosion, run by University of Göttingen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Erosion
- What is being tested?
- Collection of saliva samples and Visual detection of BEWE-index
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exploratory study
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Being tested
- Collection of saliva samples, Visual detection of BEWE-index
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of saliva samplesOther
Collection of saliva samples
Visual detection of BEWE-indexOther
Visual detection of BEWE-index
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Collection of saliva samples; Other: Visual detection of BEWE-index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of the BEWE-(basic erosive wear examination)-index
Measured: After removal of the probe (on second day)
Secondary outcomes (5)
Determination of unstimulated and stimulated saliva flow rate (ml/min).
Measured: While wearing the probe at three time points over 24h: morning, noon, evening
Determination of saliva pH and buffer capacity (mol/L).
Measured: While wearing the probe at three time points over 24h: morning, noon, evening
Determination of total protein content in saliva (g/L).
Measured: While wearing the probe at three time points over 24h: morning, noon, evening
Determination inorganic calcium and phosphate in saliva (mmol/L).
Measured: 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).
Measured: While wearing the probe at three time points over 24h: morning, noon, evening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 Nov 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental ErosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen
- Investigators
- Annette Wiegand, Prof. Dr. med. dent., Principal investigator, Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775149
- Sponsor's protocol ID
- Erosion-Reflux
- Other IDs
- 2/11/15
- Status last verified
- Nov 2020
- First submitted
- 9 May 2016
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18228057Hara 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 24993267Moazzez 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 15240067Ranjitkar 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 22004279Schlueter 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 22472533Wang 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 20696201Wilder-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 25922678Kanzow 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Erosion in Patients With Gastro-oesophageal Reflux
- ClinicalTrials.gov ID
- NCT02775149
- Acronym / sponsor ID
- Erosion-Reflux
- Conditions
- Dental Erosion
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: No participants
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reflux patients | – | Other: Collection of saliva samples, Other: Visual detection of BEWE-indexPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exploratory study
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of saliva samplesCollection of saliva samples | Other | Reflux patients |
| Visual detection of BEWE-indexVisual detection of BEWE-index | Other | Reflux patients |
Primary outcome
Visual assessment of the BEWE-(basic erosive wear examination)-index
Time frame: After removal of the probe (on second day)
5 secondary outcomes
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
Determination of saliva pH and buffer capacity (mol/L).
Time frame: While wearing the probe at three time points over 24h: morning, noon, evening
Determination of total protein content in saliva (g/L).
Time frame: While wearing the probe at three time points over 24h: morning, noon, evening
Determination inorganic calcium and phosphate in saliva (mmol/L).
Time frame: 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).
Time frame: While wearing the probe at three time points over 24h: morning, noon, evening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 18228057Bartlett 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.
- Background: PubMed 24993267Hara 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.
- Background: PubMed 15240067Moazzez 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.
- Background: PubMed 22004279Ranjitkar 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.
- Background: PubMed 22472533Schlueter 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.
- Background: PubMed 20696201Wang 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.
- Background: PubMed 25922678Wilder-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.
- Background: PubMed 27022647Kanzow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Wiegand, Prof. Dr. med. dent. principal investigator
Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Erosion, run by University of Göttingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment of the BEWE-(basic erosive wear examination)-index (time frame: After removal of the probe (on second day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775149, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.