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

February 13, 2024 updated by: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University of Göttingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Exploratory study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Females
Female volunteers
Other: Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples
Males
Male volunteers
Other: Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).
Time Frame: Immediately after the intraoral device has been worn once for two hours.
Immediately after the intraoral device has been worn once for two hours.

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of unstimulated and stimulated saliva flow rate (mL/min).
Time Frame: Saliva samples are collected for 5 min each on two visits.
Saliva samples are collected for 5 min each on two visits.
Determination of saliva pH.
Time Frame: Saliva samples are collected for 5 min each on two visits.
Saliva samples are collected for 5 min each on two visits.
Determination of salivary buffer capacity.
Time Frame: Saliva samples are collected for 5 min each on two visits.
Saliva samples are collected for 5 min each on two visits.
Determination of albumin (mg/L) in saliva.
Time Frame: Saliva samples are collected for 5 min each on two visits.
Saliva samples are collected for 5 min each on two visits.
Determination of total protein content (mg/L) in saliva.
Time Frame: Saliva samples are collected for 5 min each on two visits.
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.
Time Frame: Saliva samples are collected for 5 min each on two visits.
Saliva samples are collected for 5 min each on two visits.
Determination of total protein concentration in the formed salivary pellicles (ng/Square Millimeter).
Time Frame: Immediately after the intraoral device has been worn once for two hours.
Immediately after the intraoral device has been worn once for two hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Investigators

  • Principal Investigator: Annette Wiegand, Prof. Dr. med. dent., Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Actual)

January 18, 2018

Study Completion (Actual)

January 18, 2018

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimated)

May 24, 2016

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erosion-Gender
  • 7/10/15 (Other Identifier: Local Ethics Commission)
  • 01681 (Other Identifier: UMG study center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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