ClinicalTrials.gg
CompletedNCT02780973Updated Feb 14, 2024

Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study

An observational study in Dental Erosion, sponsored by University of Göttingen. Completed at 1 site in Germany. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by University of Göttingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Dental Erosion

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03

In context

Tooth Erosion

47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 13 observational studies indexed under Tooth Erosion.

Browse Tooth Erosion studies →

Lead sponsor

University of Göttingen is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Exploratory study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy probands aged between 20 and 40 years who are able to give written consent

Exclusion criteria

Exclusion Criteria:

  • 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Females

    Female volunteers

    Other: Wearing of an intraoral device with bovine tooth samples

  • Males

    Male volunteers

    Other: Wearing of an intraoral device with bovine tooth samples

Interventions

  • OtherWearing of an intraoral device with bovine tooth samples

    Wearing of an intraoral device with bovine tooth samples

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. Determination of unstimulated and stimulated saliva flow rate (mL/min).

    Time frame: Saliva samples are collected for 5 min each on two visits.

  2. Determination of saliva pH.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  3. Determination of salivary buffer capacity.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  4. Determination of albumin (mg/L) in saliva.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  5. Determination of total protein content (mg/L) in saliva.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  6. 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.

  7. 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.

07

Study locations

1 site
  • University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
    Göttingen, Lower Saxony 37075, Germany
08

References and documents

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 25809904 ↗
  • 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 24603346 ↗
  • Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26. PubMed 24993266 ↗
  • Wiegand 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 18607835 ↗
  • Wiegand 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 18523383 ↗
  • Zwier 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 23774653 ↗
  • 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. PubMed 27022647 ↗
  • Wiegand 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in Jan 2018, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2016
First posted
May 24, 2016
StartActual
Feb 7, 2017
Primary completionActual
Jan 18, 2018
CompletionActual
Jan 18, 2018
Last update
Feb 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02780973
Lead sponsor
University of Göttingen
Responsible party
Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic. (Senior Dental Practitioner, University Medical Center Goettingen) — Principal investigator
First posted
May 24, 2016
Start date
Feb 7, 2017
Primary completion
Jan 18, 2018
Completion
Jan 18, 2018
Last update
Feb 14, 2024

Study contacts

Annette Wiegand, Prof. Dr. med. dent.
principal investigator · Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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