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Completed

NCT Number: NCT04208802

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

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.

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Key information

Conditions

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

Age range

20 year–50 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

  • 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

Treatment and study plan

Use of fluoridated toothpaste

Other

Use of fluoridated toothpaste

Wearing of an intraoral device with bovine tooth samples

Other

Wearing of an intraoral device with bovine tooth samples

Wearing of an intraoral device with resin samples

Other

Wearing of an intraoral device with resin samples

Primary outcomes

  1. 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.

Secondary outcomes

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

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

  2. Determination of saliva pH (pH).

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

  3. Determination of salivary buffer capacity (pH).

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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2019
Registry last updated
Jan 27, 2026

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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