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

Study Overview
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Brief Summary
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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, and total protein content as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.

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

Conditions
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Dental Erosion

Intervention / Treatment
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* Other: Use of fluoridated toothpaste
* Other: Wearing of an intraoral device with bovine tooth samples
* Other: Wearing of an intraoral device with resin samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smokers<br>Volunteers smoking at least 10 cigarettes per day | Other: Use of fluoridated toothpaste<br>* Use of fluoridated toothpaste<br>Other: Wearing of an intraoral device with bovine tooth samples<br>* Wearing of an intraoral device with bovine tooth samples<br>Other: Wearing of an intraoral device with resin samples<br>* Wearing of an intraoral device with resin samples<br>|
| Non-smokers<br>Non-smoking volunteers | Other: Use of fluoridated toothpaste<br>* Use of fluoridated toothpaste<br>Other: Wearing of an intraoral device with bovine tooth samples<br>* Wearing of an intraoral device with bovine tooth samples<br>Other: Wearing of an intraoral device with resin samples<br>* Wearing of an intraoral device with resin samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of unstimulated and stimulated saliva flow rate (mL/min). |  | Saliva samples are collected for 5 min each on three visits. | 
| Determination of saliva pH (pH). |  | 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 total protein content (mg/L) in saliva. |  | Saliva samples are collected for 5 min each on three visits. | 
| 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 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. |