Clinical trial NCT02780973: Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
Official title: Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Erosion
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exploratory study

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).
timeFrame: Immediately after the intraoral device has been worn once for two hours.
Secondary outcomes:
measure: Determination of unstimulated and stimulated saliva flow rate (mL/min).
timeFrame: Saliva samples are collected for 5 min each on two visits.
measure: Determination of saliva pH.
timeFrame: Saliva samples are collected for 5 min each on two visits.
measure: Determination of salivary buffer capacity.
timeFrame: Saliva samples are collected for 5 min each on two visits.
measure: Determination of albumin (mg/L) in saliva.
timeFrame: Saliva samples are collected for 5 min each on two visits.
measure: Determination of total protein content (mg/L) in saliva.
timeFrame: Saliva samples are collected for 5 min each on two visits.
measure: Determination of inorganic calcium (mmol/l), phosphate (mmol/L) and fluoride (µmol/L) in saliva.
timeFrame: Saliva samples are collected for 5 min each on two visits.
measure: Determination of total protein concentration in the formed salivary pellicles (ng/Square Millimeter).
timeFrame: Immediately after the intraoral device has been worn once for two hours.
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
state: Lower Saxony
Study officials:
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
name: Annette Wiegand, Prof. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.