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

Sponsor
University of Göttingen (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04208802
Collaborator
(none)
50
1
27.2
1.8

Study Details

Study Description

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, and total protein content as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.

Condition or Disease Intervention/Treatment Phase
  • Other: Use of fluoridated toothpaste
  • Other: Wearing of an intraoral device with bovine tooth samples
  • Other: Wearing of an intraoral device with resin samples

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study
Actual Study Start Date :
Sep 24, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Smokers

Volunteers smoking at least 10 cigarettes per day

Other: Use of fluoridated toothpaste
Use of fluoridated toothpaste

Other: Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples

Other: Wearing of an intraoral device with resin samples
Wearing of an intraoral device with resin samples

Non-smokers

Non-smoking volunteers

Other: Use of fluoridated toothpaste
Use of fluoridated toothpaste

Other: Wearing of an intraoral device with bovine tooth samples
Wearing of an intraoral device with bovine tooth samples

Other: Wearing of an intraoral device with resin samples
Wearing of an intraoral device with resin samples

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Determination of unstimulated and stimulated saliva flow rate (mL/min). [Saliva samples are collected for 5 min each on three visits.]

  2. Determination of saliva pH (pH). [Saliva samples are collected for 5 min each on three visits.]

  3. Determination of salivary buffer capacity (pH). [Saliva samples are collected for 5 min each on three visits.]

  4. Determination of total protein content (mg/L) in saliva. [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. [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. [Immediately after the intraoral device with resin samples has been worn once for two hours.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology Göttingen Lower Saxony Germany 37075

Sponsors and Collaborators

  • University of Göttingen

Investigators

  • Principal Investigator: Annette Wiegand, Prof. Dr. med. dent., Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., Senior Dental Practitioner, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT04208802
Other Study ID Numbers:
  • Erosion-Smoking
  • 15/10/19
  • 02785
First Posted:
Dec 23, 2019
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2022