Dental Erosion Clinical Trial
Official title:
Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
Verified date | February 2024 |
Source | University of Göttingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology | Göttingen | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
University of Göttingen |
Germany,
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
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. |
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