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Completed

NCT Number: NCT02780973

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

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.

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Key information

Conditions

Dental Erosion Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Göttingen, Lower Saxony, 37075, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearing of an intraoral device with bovine tooth samples

Other

Wearing of an intraoral device with bovine tooth samples

Primary outcomes

  1. 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.

Secondary outcomes

  1. Determination of unstimulated and stimulated saliva flow rate (mL/min).

    Time frame: Saliva samples are collected for 5 min each on two visits.

  2. Determination of saliva pH.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  3. Determination of salivary buffer capacity.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  4. Determination of albumin (mg/L) in saliva.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  5. Determination of total protein content (mg/L) in saliva.

    Time frame: Saliva samples are collected for 5 min each on two visits.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2016
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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