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

Sponsor
University of Göttingen (Other)
Overall Status
Completed
CT.gov ID
NCT02780973
Collaborator
(none)
50
1
11.3
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Wearing of an intraoral device with bovine tooth samples

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study
Actual Study Start Date :
Feb 7, 2017
Actual Primary Completion Date :
Jan 18, 2018
Actual Study Completion Date :
Jan 18, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Determination of unstimulated and stimulated saliva flow rate (mL/min). [Saliva samples are collected for 5 min each on two visits.]

  2. Determination of saliva pH. [Saliva samples are collected for 5 min each on two visits.]

  3. Determination of salivary buffer capacity. [Saliva samples are collected for 5 min each on two visits.]

  4. Determination of albumin (mg/L) in saliva. [Saliva samples are collected for 5 min each on two visits.]

  5. Determination of total protein content (mg/L) in saliva. [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. [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). [Immediately after the intraoral device has been worn once for two hours.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology Göttingen Lower Saxony Germany 37075

Sponsors and Collaborators

  • University of Göttingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., Senior Dental Practitioner, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT02780973
Other Study ID Numbers:
  • Erosion-Gender
  • 7/10/15
  • 01681
First Posted:
May 24, 2016
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021