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CompletedNCT04208802Updated Jan 27, 2026

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

An observational study in Dental Erosion, sponsored by University of Göttingen. Completed at 1 site in Germany. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by University of Göttingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

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Conditions studied

  • Dental Erosion

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03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Exploratory study

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Smokers

    Volunteers smoking at least 10 cigarettes per day

    Other: Use of fluoridated toothpaste · Other: Wearing of an intraoral device with bovine tooth samples · Other: Wearing of an intraoral device with resin samples

  • Non-smokers

    Non-smoking volunteers

    Other: Use of fluoridated toothpaste · Other: Wearing of an intraoral device with bovine tooth samples · Other: Wearing of an intraoral device with resin samples

Interventions

  • OtherUse of fluoridated toothpaste

    Use of fluoridated toothpaste

  • OtherWearing of an intraoral device with bovine tooth samples

    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

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What researchers measure

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.

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Study locations

1 site
  • University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
    Göttingen, Lower Saxony 37075, Germany
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References and documents

Publications

  • 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. PubMed 24603346 ↗
  • Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26. PubMed 24993266 ↗
  • 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. PubMed 18607835 ↗
  • 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. PubMed 18523383 ↗
  • 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. PubMed 23774653 ↗
  • 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. PubMed 27022647 ↗
  • 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. PubMed 31163440 ↗
  • Kanzow P, Lenz C, Schlarmann F, Barke S, Rohland B, Schmidt A, Gorshkova A, Neuenroth L, Wiegand A. Saliva and salivary pellicle composition and proteomic profile in smokers vs. non-smokers and its effect on dental erosion. J Dent. 2026 Mar;166:106517. doi: 10.1016/j.jdent.2026.106517. Epub 2026 Jan 21. PubMed 41577165 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT04208802
Lead sponsor
University of Göttingen
Responsible party
Philipp Kanzow, Prof. Dr. med. dent., Dr. rer. medic. (Senior Dental Practitioner, University Medical Center Goettingen) — Principal investigator
First posted
Dec 23, 2019
Start date
Sep 24, 2020
Primary completion
Jul 29, 2022
Completion
Jul 29, 2022
Last update
Jan 27, 2026

Study contacts

Annette Wiegand, Prof. Dr. med. dent.
principal investigator · Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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