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

Completed

• Conditions: Dental Erosion
• Interventions: Other: Use of fluoridated toothpaste; Other: Wearing of an intraoral device with bovine tooth samples; Other: Wearing of an intraoral device with resin samples

• Registration Number: NCT04208802
• Lead Sponsor: University of Göttingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Study Start: 2020-09-24
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smokers	Wearing of an intraoral device with resin samples	Volunteers smoking at least 10 cigarettes per day
Non-smokers	Use of fluoridated toothpaste	Non-smoking volunteers
Non-smokers	Wearing of an intraoral device with resin samples	Non-smoking volunteers
Smokers	Wearing of an intraoral device with bovine tooth samples	Volunteers smoking at least 10 cigarettes per day
Smokers	Use of fluoridated toothpaste	Volunteers smoking at least 10 cigarettes per day
Non-smokers	Wearing of an intraoral device with bovine tooth samples	Non-smoking volunteers

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Determination of salivary buffer capacity (pH).	Saliva samples are collected for 5 min each on three visits.
Determination of unstimulated and stimulated saliva flow rate (mL/min).	Saliva samples are collected for 5 min each on three visits.
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.
Determination of saliva pH (pH).	Saliva samples are collected for 5 min each on three visits.
Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.	Saliva samples are collected for 5 min each on three visits.

Trial Locations

Locations (1)

University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology; 🇩🇪 Göttingen, Lower Saxony, Germany