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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
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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.

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Conditions studied

  • Dental Erosion

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03

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

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 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
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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

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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.

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Study locations

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

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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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