Effect of Smoking on Saliva Composition and the Development of Dental Erosion

Dental Erosion Clinical Trial

Official title:

Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208802
• Other study ID #: Erosion-Smoking
• Secondary ID: 15/10/1902785
• Status: Completed
• Start date: September 24, 2020
• Est. completion date: July 29, 2022

Study information

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

Clinical Trial Summary

The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion. Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured. Total protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Volunteers aged between 20 and 50 years who are able to give written consent

Exclusion Criteria:

• Non-fulfillment of the inclusion criteria
• Intake of medications or diseases altering salivary secretion
• Refusal to use fluoridated toothpastes
• Known allergies to substances used in the study
• Orthodontic treatment or malfunction which does not allow wearing an intraoral device

Related Conditions & MeSH terms

• Dental Erosion
• Tooth Erosion

Intervention

Other:
• Use of fluoridated toothpaste
Use of fluoridated toothpaste
• Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples
• Wearing of an intraoral device with resin samples
Wearing of an intraoral device with resin 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 (7)

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

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 specimens 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 three visits.
Secondary	Determination of saliva pH (pH).		Saliva samples are collected for 5 min each on three visits.
Secondary	Determination of salivary buffer capacity (pH).		Saliva samples are collected for 5 min each on three visits.
Secondary	Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.		Saliva samples are collected for 5 min each on three 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 three visits.
Secondary	Determination of total protein concentration (ng/Square Millimeter) and protein composition (qualitatively) within the salivary pellicles.		Immediately after the intraoral device with resin samples has been worn once for two hours.