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

NCT02780973 | Completed

• 3 other identifiers: Erosion-Gender7/10/1501681
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Erosion

Outcome Measures

Primary Outcomes (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 Outcomes (7)

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

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

• 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 total protein content (mg/L) in saliva.

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

Study Arms (2)

Females

Female volunteers

Other: Wearing of an intraoral device with bovine tooth samples

Males

Male volunteers

Other: Wearing of an intraoral device with bovine tooth samples

Interventions

Wearing of an intraoral device with bovine tooth samples OTHER

Wearing of an intraoral device with bovine tooth samples

Females; Males

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Exploratory study

You may qualify if:

• Healthy probands aged between 20 and 40 years who are able to give written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Göttingen: lead

Study Sites (1)

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

Göttingen, Lower Saxony, 37075, Germany

Location

Related Publications (8)

• Prodan A, Brand HS, Ligtenberg AJ, Imangaliyev S, Tsivtsivadze E, van der Weijden F, Crielaard W, Keijser BJ, Veerman EC. Interindividual variation, correlations, and sex-related differences in the salivary biochemistry of young healthy adults. Eur J Oral Sci. 2015 Jun;123(3):149-57. doi: 10.1111/eos.12182. Epub 2015 Mar 23.

  PMID: 25809904 BACKGROUND

• Carpenter G, Cotroneo E, Moazzez R, Rojas-Serrano M, Donaldson N, Austin R, Zaidel L, Bartlett D, Proctor G. Composition of enamel pellicle from dental erosion patients. Caries Res. 2014;48(5):361-7. doi: 10.1159/000356973. Epub 2014 Mar 6.

  PMID: 24603346 BACKGROUND

• Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26.

  PMID: 24993266 BACKGROUND

• Wiegand A, Bliggenstorfer S, Magalhaes AC, Sener B, Attin T. Impact of the in situ formed salivary pellicle on enamel and dentine erosion induced by different acids. Acta Odontol Scand. 2008 Aug;66(4):225-30. doi: 10.1080/00016350802183401.

  PMID: 18607835 BACKGROUND

• Wiegand A, Meier W, Sutter E, Magalhaes AC, Becker K, Roos M, Attin T. Protective effect of different tetrafluorides on erosion of pellicle-free and pellicle-covered enamel and dentine. Caries Res. 2008;42(4):247-54. doi: 10.1159/000135669. Epub 2008 Jun 4.

  PMID: 18523383 BACKGROUND

• Zwier N, Huysmans MC, Jager DH, Ruben J, Bronkhorst EM, Truin GJ. Saliva parameters and erosive wear in adolescents. Caries Res. 2013;47(6):548-52. doi: 10.1159/000350361. Epub 2013 Jun 15.

  PMID: 23774653 BACKGROUND

• Kanzow P, Wegehaupt FJ, Attin T, Wiegand A. Etiology and pathogenesis of dental erosion. Quintessence Int. 2016 Apr;47(4):275-8. doi: 10.3290/j.qi.a35625.

  PMID: 27022647 BACKGROUND

• Wiegand A, Rosemann A, Hoch M, Barke S, Dakna M, Kanzow P. Erosion-Protective Capacity of the Salivary Pellicle of Female and Male Subjects Is Not Different. Caries Res. 2019;53(6):636-642. doi: 10.1159/000500046. Epub 2019 Jun 4.

  PMID: 31163440 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples are obtained and retained for 10 years.

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Annette Wiegand, Prof. Dr. med. dent.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Dental Practitioner

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 24, 2016
• Study Start: February 7, 2017
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)