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Effect of Smoking on Saliva Composition and the Development of Dental Erosion

Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04208802
Enrollment
50
Registered
2019-12-23
Start date
2020-09-24
Completion date
2022-07-29
Last updated
2026-01-27

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

Conditions

Dental Erosion

Brief summary

The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion. Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured. Total protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.

Interventions

Use of fluoridated toothpaste

Wearing of an intraoral device with bovine tooth samples

OTHERWearing of an intraoral device with resin samples

Wearing of an intraoral device with resin samples

Sponsors

University of Göttingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Volunteers aged between 20 and 50 years who are able to give written consent

Exclusion criteria

* Non-fulfillment of the inclusion criteria * Intake of medications or diseases altering salivary secretion * Refusal to use fluoridated toothpastes * Known allergies to substances used in the study * Orthodontic treatment or malfunction which does not allow wearing an intraoral device

Design outcomes

Primary

MeasureTime frame
Calcium release from bovine enamel and dentin specimens by extraoral erosion (nmol/Square Millimeter).Immediately after the intraoral device has been worn once for two hours.

Secondary

MeasureTime frame
Determination of unstimulated and stimulated saliva flow rate (mL/min).Saliva samples are collected for 5 min each on three visits.
Determination of salivary buffer capacity (pH).Saliva samples are collected for 5 min each on three visits.
Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.Saliva samples are collected for 5 min each on three 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 three visits.
Determination of total protein concentration (ng/Square Millimeter) and protein composition (qualitatively) within the salivary pellicles.Immediately after the intraoral device with resin samples has been worn once for two hours.
Determination of saliva pH (pH).Saliva samples are collected for 5 min each on three visits.

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORAnnette Wiegand, Prof. Dr. med. dent.

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

Outcome results

None listed

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