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

Completed

• Conditions: Dental Erosion
• Interventions: Other: Wearing of an intraoral device with bovine tooth samples

• Registration Number: NCT02780973
• Lead Sponsor: University of Göttingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Study Start: 2017-02-07
• Primary Completion: 2018-01-18
• Study Completion: 2018-01-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Males	Wearing of an intraoral device with bovine tooth samples	Male volunteers
Females	Wearing of an intraoral device with bovine tooth samples	Female volunteers

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determination of saliva pH.	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 unstimulated and stimulated saliva flow rate (mL/min).	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 total protein concentration in the formed salivary pellicles (ng/Square Millimeter).	Immediately after the intraoral device has been worn once for two hours.
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.

Trial Locations

Locations (1)

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