Dental ErosionNCT04208802
Effect of Smoking on Saliva Composition and the Development of Dental Erosion
An observational study of Dental Erosion, run by University of Göttingen at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion. Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Erosion
- What is being tested?
- Use of fluoridated toothpaste, Wearing of an intraoral device with bovine tooth samples and Wearing of an intraoral device with resin samples
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2020to 29 Jul 2022
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Exploratory study
Who may be able to join
- Volunteers aged between 20 and 50 years who are able to give written consent
Who cannot join
- Non-fulfillment of the inclusion criteria
- Intake of medications or diseases altering salivary secretion
- Refusal to use fluoridated toothpastes
- Known allergies to substances used in the study
- Orthodontic treatment or malfunction which does not allow wearing an intraoral device
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
Göttingen, Lower Saxony, 37075
About this study
Official title: Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study
The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion.
Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured.
Total protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.
- Conditions
- Dental Erosion
- Being tested
- Use of fluoridated toothpaste, Wearing of an intraoral device with bovine tooth samples, Wearing of an intraoral device with resin samples
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of fluoridated toothpasteOther
Use of fluoridated toothpaste
Wearing of an intraoral device with bovine tooth samplesOther
Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with resin samplesOther
Wearing of an intraoral device with resin samples
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Volunteers smoking at least 10 cigarettes per day Receives: Other: Use of fluoridated toothpaste; Other: Wearing of an intraoral device with bovine tooth samples; Other: Wearing of an intraoral device with resin samples | |
| Non-smokers | Non-smoking volunteers Receives: Other: Use of fluoridated toothpaste; Other: Wearing of an intraoral device with bovine tooth samples; Other: Wearing of an intraoral device with resin samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium release from bovine enamel and dentin specimens by extraoral erosion (nmol/Square Millimeter).
Measured: Immediately after the intraoral device has been worn once for two hours.
Secondary outcomes (6)
Determination of unstimulated and stimulated saliva flow rate (mL/min).
Measured: Saliva samples are collected for 5 min each on three visits.
Determination of saliva pH (pH).
Measured: Saliva samples are collected for 5 min each on three visits.
Determination of salivary buffer capacity (pH).
Measured: Saliva samples are collected for 5 min each on three visits.
Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.
Measured: Saliva samples are collected for 5 min each on three visits.
Determination of inorganic calcium (mmol/L), phosphate (mmol/L) and fluoride (µmol/L) in saliva.
Measured: Saliva samples are collected for 5 min each on three visits.
Determination of total protein concentration (ng/Square Millimeter) and protein composition (qualitatively) within the salivary pellicles.
Measured: Immediately after the intraoral device with resin samples has been worn once for two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start24 Sep 2020
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kanzow, Prof. 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
- NCT04208802
- Sponsor's protocol ID
- Erosion-Smoking
- Other IDs
- 15/10/19, 02785
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2019
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpenter G, Cotroneo E, Moazzez R, Rojas-Serrano M, Donaldson N, Austin R, Zaidel L, Bartlett D, Proctor G. Composition of enamel pellicle from dental erosion patients. Caries Res. 2014;48(5):361-7. doi: 10.1159/000356973. Epub 2014 Mar 6.
PubMed 24603346Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26.
PubMed 24993266Wiegand A, Bliggenstorfer S, Magalhaes AC, Sener B, Attin T. Impact of the in situ formed salivary pellicle on enamel and dentine erosion induced by different acids. Acta Odontol Scand. 2008 Aug;66(4):225-30. doi: 10.1080/00016350802183401.
PubMed 18607835Wiegand A, Meier W, Sutter E, Magalhaes AC, Becker K, Roos M, Attin T. Protective effect of different tetrafluorides on erosion of pellicle-free and pellicle-covered enamel and dentine. Caries Res. 2008;42(4):247-54. doi: 10.1159/000135669. Epub 2008 Jun 4.
PubMed 18523383Zwier N, Huysmans MC, Jager DH, Ruben J, Bronkhorst EM, Truin GJ. Saliva parameters and erosive wear in adolescents. Caries Res. 2013;47(6):548-52. doi: 10.1159/000350361. Epub 2013 Jun 15.
PubMed 23774653Kanzow 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 27022647Wiegand A, Rosemann A, Hoch M, Barke S, Dakna M, Kanzow P. Erosion-Protective Capacity of the Salivary Pellicle of Female and Male Subjects Is Not Different. Caries Res. 2019;53(6):636-642. doi: 10.1159/000500046. Epub 2019 Jun 4.
PubMed 31163440Kanzow P, Lenz C, Schlarmann F, Barke S, Rohland B, Schmidt A, Gorshkova A, Neuenroth L, Wiegand A. Saliva and salivary pellicle composition and proteomic profile in smokers vs. non-smokers and its effect on dental erosion. J Dent. 2026 Mar;166:106517. doi: 10.1016/j.jdent.2026.106517. Epub 2026 Jan 21.
PubMed 41577165
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study
- ClinicalTrials.gov ID
- NCT04208802
- Acronym / sponsor ID
- Erosion-Smoking
- Conditions
- Dental Erosion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 23 Dec 2019 (actual)
- 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.
The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion.
Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured.
Total protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Other: Use of fluoridated toothpaste, Other: Wearing of an intraoral device with bovine tooth samples, Other: Wearing of an intraoral device with resin samplesVolunteers smoking at least 10 cigarettes per day |
| Non-smokers | – | Other: Use of fluoridated toothpaste, Other: Wearing of an intraoral device with bovine tooth samples, Other: Wearing of an intraoral device with resin samplesNon-smoking volunteers |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Exploratory study
Key inclusion criteria (1 listed)
- Volunteers aged between 20 and 50 years who are able to give written consent
Key exclusion criteria (5 listed)
- Non-fulfillment of the inclusion criteria
- Intake of medications or diseases altering salivary secretion
- Refusal to use fluoridated toothpastes
- Known allergies to substances used in the study
- Orthodontic treatment or malfunction which does not allow wearing an intraoral device
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 |
|---|---|---|
| Use of fluoridated toothpasteUse of fluoridated toothpaste | Other | Non-smokers, Smokers |
| Wearing of an intraoral device with bovine tooth samplesWearing of an intraoral device with bovine tooth samples | Other | Non-smokers, Smokers |
| Wearing of an intraoral device with resin samplesWearing of an intraoral device with resin samples | Other | Non-smokers, Smokers |
Primary outcome
Calcium release from bovine enamel and dentin specimens by extraoral erosion (nmol/Square Millimeter).
Time frame: Immediately after the intraoral device has been worn once for two hours.
6 secondary outcomes
Determination of unstimulated and stimulated saliva flow rate (mL/min).
Time frame: Saliva samples are collected for 5 min each on three visits.
Determination of saliva pH (pH).
Time frame: Saliva samples are collected for 5 min each on three visits.
Determination of salivary buffer capacity (pH).
Time frame: Saliva samples are collected for 5 min each on three visits.
Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.
Time frame: Saliva samples are collected for 5 min each on three visits.
Determination of inorganic calcium (mmol/L), phosphate (mmol/L) and fluoride (µmol/L) in saliva.
Time frame: Saliva samples are collected for 5 min each on three visits.
Determination of total protein concentration (ng/Square Millimeter) and protein composition (qualitatively) within the salivary pellicles.
Time frame: Immediately after the intraoral device with resin samples has been worn once for two hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 24603346Carpenter G, Cotroneo E, Moazzez R, Rojas-Serrano M, Donaldson N, Austin R, Zaidel L, Bartlett D, Proctor G. Composition of enamel pellicle from dental erosion patients. Caries Res. 2014;48(5):361-7. doi: 10.1159/000356973. Epub 2014 Mar 6.
- Background: PubMed 24993266Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26.
- Background: PubMed 18607835Wiegand A, Bliggenstorfer S, Magalhaes AC, Sener B, Attin T. Impact of the in situ formed salivary pellicle on enamel and dentine erosion induced by different acids. Acta Odontol Scand. 2008 Aug;66(4):225-30. doi: 10.1080/00016350802183401.
- Background: PubMed 18523383Wiegand A, Meier W, Sutter E, Magalhaes AC, Becker K, Roos M, Attin T. Protective effect of different tetrafluorides on erosion of pellicle-free and pellicle-covered enamel and dentine. Caries Res. 2008;42(4):247-54. doi: 10.1159/000135669. Epub 2008 Jun 4.
- Background: PubMed 23774653Zwier N, Huysmans MC, Jager DH, Ruben J, Bronkhorst EM, Truin GJ. Saliva parameters and erosive wear in adolescents. Caries Res. 2013;47(6):548-52. doi: 10.1159/000350361. Epub 2013 Jun 15.
- 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.
- Background: PubMed 31163440Wiegand A, Rosemann A, Hoch M, Barke S, Dakna M, Kanzow P. Erosion-Protective Capacity of the Salivary Pellicle of Female and Male Subjects Is Not Different. Caries Res. 2019;53(6):636-642. doi: 10.1159/000500046. Epub 2019 Jun 4.
- Results publication: PubMed 41577165Kanzow P, Lenz C, Schlarmann F, Barke S, Rohland B, Schmidt A, Gorshkova A, Neuenroth L, Wiegand A. Saliva and salivary pellicle composition and proteomic profile in smokers vs. non-smokers and its effect on dental erosion. J Dent. 2026 Mar;166:106517. doi: 10.1016/j.jdent.2026.106517. Epub 2026 Jan 21.
- 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
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, run by University of Göttingen at 1 site in Germany.
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 5 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: finished, as of the sponsor's last update on 27 Jan 2026. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calcium release from bovine enamel and dentin specimens by extraoral erosion (nmol/Square Millimeter). (time frame: Immediately after the intraoral device has been worn once for two hours.). 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 NCT04208802, 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 27 Jan 2026.