Dental ErosionNCT02087345
Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion
An observational study of Dental Erosion and Gastroesophageal Reflux, run by Brain-Gut Research Group at 1 site in Switzerland.
Trial summary
Dental erosions, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Erosion, Gastroesophageal Reflux
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2018to Jun 2023
- 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: Successive male and female patients with dental erosions
Who may be able to join
- Successive male and female patients
- Over 18 years of age presenting to the University of Bern Department of Dentistry and affiliated dentists
- Dental erosions
Who cannot join
- Non-reflux causes of erosion
- Reduced salivary flow and buffering capacity
- History of bruxism, eating disorders, recurrent vomiting, severe obesity (BMI>35kg/m2) or past bariatric surgery
- Dietary or abrasive causes for dental erosion
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Gastroenterology Group Practice
Bern
Clive Wilder-Smith, MD, +41313123737, info@ggp.ch
Clive Wilder-Smith, MD
About this study
Official title: Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring
Dental erosions, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Given the high prevalence of dental erosions and the absence of any pH-impedance data or medical management guidelines for GERD-associated dental erosions, reflux characteristics will be characterized using questionnaires, endoscopy and esophageal pH-impedance testing, in successive patients dental erosions referred by dentists for evaluation of GERD. For assessment of the role of additional factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.
- Conditions
- Dental Erosion, Gastroesophageal Reflux
- Medical subject headings
- Tooth Erosion, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dental erosions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The % of time with pH<4 and 5.5 during 24-hour pH-impedance
Measured: 1 year
Secondary outcomes (1)
The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study start15 Dec 2018
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clive Wilder-Smith, MD, Principal investigator, Brain-Gut Reserach Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087345
- Sponsor's protocol ID
- BGRG-2414b
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2014
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wilder-Smith CH, Materna A, Martig L, Lussi A. Longitudinal study of gastroesophageal reflux and erosive tooth wear. BMC Gastroenterol. 2017 Oct 25;17(1):113. doi: 10.1186/s12876-017-0670-1.
PubMed 29070010
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring
- ClinicalTrials.gov ID
- NCT02087345
- Acronym / sponsor ID
- BGRG-2414b
- Conditions
- Dental Erosion, Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 14 Mar 2014 (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.
Dental erosions, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Given the high prevalence of dental erosions and the absence of any pH-impedance data or medical management guidelines for GERD-associated dental erosions, reflux characteristics will be characterized using questionnaires, endoscopy and esophageal pH-impedance testing, in successive patients dental erosions referred by dentists for evaluation of GERD. For assessment of the role of additional factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental erosions | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Successive male and female patients with dental erosions
Key inclusion criteria (3 listed)
- Successive male and female patients
- Over 18 years of age presenting to the University of Bern Department of Dentistry and affiliated dentists
- Dental erosions
Key exclusion criteria (4 listed)
- Non-reflux causes of erosion
- Reduced salivary flow and buffering capacity
- History of bruxism, eating disorders, recurrent vomiting, severe obesity (BMI>35kg/m2) or past bariatric surgery
- Dietary or abrasive causes for dental erosion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The % of time with pH<4 and 5.5 during 24-hour pH-impedance
Time frame: 1 year
1 secondary outcome
The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 29070010Wilder-Smith CH, Materna A, Martig L, Lussi A. Longitudinal study of gastroesophageal reflux and erosive tooth wear. BMC Gastroenterol. 2017 Oct 25;17(1):113. doi: 10.1186/s12876-017-0670-1.
- 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.
Clive Wilder-Smith, MD principal investigator
Brain-Gut Reserach Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Erosion and Gastroesophageal Reflux, run by Brain-Gut Research Group at 1 site in Switzerland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Clive Wilder-Smith, MD (+41313123737, info@ggp.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The % of time with pH<4 and 5.5 during 24-hour pH-impedance (time frame: 1 year). 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 NCT02087345, which also lists 1 linked publication.
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 30 Mar 2021.