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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Dental Erosion

Intervention / Treatment
-----------------
* Other: Wearing of an intraoral device with bovine tooth samples


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females<br>Female volunteers | Other: Wearing of an intraoral device with bovine tooth samples<br>* Wearing of an intraoral device with bovine tooth samples<br>|
| Males<br>Male volunteers | Other: Wearing of an intraoral device with bovine tooth samples<br>* Wearing of an intraoral device with bovine tooth samples<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 two visits. | 
| Determination of saliva pH. |  | Saliva samples are collected for 5 min each on two visits. | 
| Determination of salivary buffer capacity. |  | Saliva samples are collected for 5 min each on two visits. | 
| Determination of albumin (mg/L) in saliva. |  | Saliva samples are collected for 5 min each on two visits. | 
| Determination of total protein content (mg/L) in saliva. |  | Saliva samples are collected for 5 min each on two 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 two visits. | 
| 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. |