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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02780973
Enrollment
50
Registered
2016-05-24
Start date
2017-02-07
Completion date
2018-01-18
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Erosion

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.

Interventions

Wearing of an intraoral device with bovine tooth samples

Sponsors

University of Göttingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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 unstimulated and stimulated saliva flow rate (mL/min).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.
Determination of total protein content (mg/L) in saliva.Saliva samples are collected for 5 min each on two visits.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026