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

January 24, 2026 updated by: Philipp Kanzow, Prof. Dr. med. dent., Dr. rer. medic., University of Göttingen

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

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.

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Exploratory study

Description

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

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
Smokers
Volunteers smoking at least 10 cigarettes per day
Other: Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples
Other: Use of fluoridated toothpaste
Use of fluoridated toothpaste
Other: Wearing of an intraoral device with resin samples
Wearing of an intraoral device with resin samples
Non-smokers
Non-smoking volunteers
Other: Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples
Other: Use of fluoridated toothpaste
Use of fluoridated toothpaste
Other: Wearing of an intraoral device with resin samples
Wearing of an intraoral device with resin samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calcium release from bovine enamel and dentin specimens 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 three visits.
Saliva samples are collected for 5 min each on three visits.
Determination of saliva pH (pH).
Time Frame: Saliva samples are collected for 5 min each on three visits.
Saliva samples are collected for 5 min each on three visits.
Determination of salivary buffer capacity (pH).
Time Frame: Saliva samples are collected for 5 min each on three visits.
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.
Time Frame: Immediately after the intraoral device with resin samples has been worn once for two hours.
Immediately after the intraoral device with resin samples has been worn once for two hours.
Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.
Time Frame: Saliva samples are collected for 5 min each on three visits.
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.
Time Frame: Saliva samples are collected for 5 min each on three visits.
Saliva samples are collected for 5 min each on three visits.

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)

September 24, 2020

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

July 29, 2022

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erosion-Smoking
  • 15/10/19 (Other Identifier: Local Ethics Commission)
  • 02785 (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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