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

Dental Erosion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780973
• Other study ID #: Erosion-Gender
• Secondary ID: 7/10/1501681
• Status: Completed
• Start date: February 7, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: February 2024
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Erosion
• Tooth Erosion

Intervention

Other:
• Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology	Göttingen	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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. — View 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. — View Citation

Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).		Immediately after the intraoral device has been worn once for two hours.
Secondary	Determination of unstimulated and stimulated saliva flow rate (mL/min).		Saliva samples are collected for 5 min each on two visits.
Secondary	Determination of saliva pH.		Saliva samples are collected for 5 min each on two visits.
Secondary	Determination of salivary buffer capacity.		Saliva samples are collected for 5 min each on two visits.
Secondary	Determination of albumin (mg/L) in saliva.		Saliva samples are collected for 5 min each on two visits.
Secondary	Determination of total protein content (mg/L) in saliva.		Saliva samples are collected for 5 min each on two visits.
Secondary	Determination of inorganic calcium (mmol/l), phosphate (mmol/L) and fluoride (µmol/L) in saliva.		Saliva samples are collected for 5 min each on two visits.
Secondary	Determination of total protein concentration in the formed salivary pellicles (ng/Square Millimeter).		Immediately after the intraoral device has been worn once for two hours.