Dental ErosionNCT02780973
Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
An observational study of Dental Erosion, run by University of Göttingen at 1 site in Germany.
Trial summary
Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is measured after extraoral erosion. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Erosion
- What is being tested?
- Wearing of an intraoral device with bovine tooth samples
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 7 Feb 2017to 18 Jan 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Exploratory study
Who may be able to join
- Healthy probands aged between 20 and 40 years who are able to give written consent
Who cannot join
- Non-fulfillment of the inclusion criteria
- Smoking
- Hyposalivation / xerostomia (unstimulated saliva < 0.3 mL/min, stimulated saliva < 0.7 mL/min)
- Intake of any medication (except contraceptives in women)
- Pregnant or lactating women
- Known allergies to substances used in the study
- Orthodontic treatment or malfunction which doesn't allow to wear 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
Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is measured after extraoral erosion.
Total protein concentration within the formed salivary pellicles on the bovine samples is determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, albumin and total protein content as well as concentration of inorganic calcium, phosphate and fluoride) are being measured.
The aim of this study is to investigate whether gender differences in the salivary composition correlate with predisposition to erosion.
- Conditions
- Dental Erosion
- Being tested
- Wearing of an intraoral device with bovine tooth 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.
Wearing of an intraoral device with bovine tooth samplesOther
Wearing of an intraoral device with bovine tooth samples
| Study group | Role | What they receive |
|---|---|---|
| Females | Female volunteers Receives: Other: Wearing of an intraoral device with bovine tooth samples | |
| Males | Male volunteers Receives: Other: Wearing of an intraoral device with bovine tooth 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 samples by extraoral erosion (nmol/Square Millimeter).
Measured: Immediately after the intraoral device has been worn once for two hours.
Secondary outcomes (7)
Determination of unstimulated and stimulated saliva flow rate (mL/min).
Measured: Saliva samples are collected for 5 min each on two visits.
Determination of saliva pH.
Measured: Saliva samples are collected for 5 min each on two visits.
Determination of salivary buffer capacity.
Measured: Saliva samples are collected for 5 min each on two visits.
Determination of albumin (mg/L) in saliva.
Measured: Saliva samples are collected for 5 min each on two visits.
Determination of total protein content (mg/L) in saliva.
Measured: Saliva samples are collected for 5 min each on two 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 two visits.
Determination of total protein concentration in the formed salivary pellicles (ng/Square Millimeter).
Measured: Immediately after the intraoral device 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 posted24 May 2016 (estimated)
- Study start7 Feb 2017
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
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, PD 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
- NCT02780973
- Sponsor's protocol ID
- Erosion-Gender
- Other IDs
- 7/10/15, 01681
- Status last verified
- Feb 2024
- First submitted
- 9 May 2016
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prodan A, Brand HS, Ligtenberg AJ, Imangaliyev S, Tsivtsivadze E, van der Weijden F, Crielaard W, Keijser BJ, Veerman EC. Interindividual variation, correlations, and sex-related differences in the salivary biochemistry of young healthy adults. Eur J Oral Sci. 2015 Jun;123(3):149-57. doi: 10.1111/eos.12182. Epub 2015 Mar 23.
PubMed 25809904Carpenter 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 31163440
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
- ClinicalTrials.gov ID
- NCT02780973
- Acronym / sponsor ID
- Erosion-Gender
- Conditions
- Dental Erosion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 24 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.
Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is measured after extraoral erosion.
Total protein concentration within the formed salivary pellicles on the bovine samples is determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, albumin and total protein content as well as concentration of inorganic calcium, phosphate and fluoride) are being measured.
The aim of this study is to investigate whether gender differences in the salivary composition correlate with predisposition to erosion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females | – | Other: Wearing of an intraoral device with bovine tooth samplesFemale volunteers |
| Males | – | Other: Wearing of an intraoral device with bovine tooth samplesMale volunteers |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Exploratory study
Key inclusion criteria (1 listed)
- Healthy probands aged between 20 and 40 years who are able to give written consent
Key exclusion criteria (7 listed)
- Non-fulfillment of the inclusion criteria
- Smoking
- Hyposalivation / xerostomia (unstimulated saliva < 0.3 mL/min, stimulated saliva < 0.7 mL/min)
- Intake of any medication (except contraceptives in women)
- Pregnant or lactating women
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 |
|---|---|---|
| Wearing of an intraoral device with bovine tooth samplesWearing of an intraoral device with bovine tooth samples | Other | Females, Males |
Primary outcome
Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).
Time frame: Immediately after the intraoral device has been worn once for two hours.
7 secondary outcomes
Determination of unstimulated and stimulated saliva flow rate (mL/min).
Time frame: Saliva samples are collected for 5 min each on two visits.
Determination of saliva pH.
Time frame: Saliva samples are collected for 5 min each on two visits.
Determination of salivary buffer capacity.
Time frame: Saliva samples are collected for 5 min each on two visits.
Determination of albumin (mg/L) in saliva.
Time frame: Saliva samples are collected for 5 min each on two visits.
Determination of total protein content (mg/L) in saliva.
Time frame: Saliva samples are collected for 5 min each on two 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 two visits.
Determination of total protein concentration in the formed salivary pellicles (ng/Square Millimeter).
Time frame: Immediately after the intraoral device 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 14 Feb 2024.
- Background: PubMed 25809904Prodan A, Brand HS, Ligtenberg AJ, Imangaliyev S, Tsivtsivadze E, van der Weijden F, Crielaard W, Keijser BJ, Veerman EC. Interindividual variation, correlations, and sex-related differences in the salivary biochemistry of young healthy adults. Eur J Oral Sci. 2015 Jun;123(3):149-57. doi: 10.1111/eos.12182. Epub 2015 Mar 23.
- 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.
- Results publication: 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.
- 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 7 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 14 Feb 2024. 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 samples 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 NCT02780973, 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 14 Feb 2024.