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

NCT04208802 | Completed

• 3 other identifiers: Erosion-Smoking15/10/1902785
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Erosion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

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

• Determination of saliva pH (pH).

  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.

Study Arms (2)

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

Wearing of an intraoral device with resin samples OTHER

Wearing of an intraoral device with resin samples

Non-smokers; Smokers

Use of fluoridated toothpaste OTHER

Use of fluoridated toothpaste

Non-smokers; Smokers

Wearing of an intraoral device with bovine tooth samples OTHER

Wearing of an intraoral device with bovine tooth samples

Non-smokers; Smokers

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Exploratory study

You may qualify if:

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

You may not qualify if:

• 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

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)

• 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 BACKGROUND

• 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.

  PMID: 41577165 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: December 18, 2019
• First Posted: December 23, 2019
• Study Start: September 24, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)