Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosi… (NCT02780973) | Clinical Trial Compass
CompletedNot Applicable
Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
Germany50 participantsStarted 2017-02-07
Plain-language 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.
Who can participate
Age range
20 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).
Timeframe: Immediately after the intraoral device has been worn once for two hours.