MedTrace Logo

Cytogenetic Damage in Buccal Cells Caused by Toothpaste

NCT03325400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-30

No results posted yet for this study

Summary

Objectives. Toothpaste contains many potentially harmful ingredients, including some that can lead to serious long-term health problems. Everyday use of oral health care products has increased, highlighting the need for healthcare clinicians and consumers to be informed of the potential benefits and risks associated with these products. The aim of this study is to evaluate possible DNA damages to oral epithelial cells in participants exposed to toothpaste containing fluoride as opposed to the effects of non-fluoride toothpaste.

Materials and Methods. Forty volunteers were selected among students of dental medicine and assigned into two experimental groups. Each group used regular non-fluoride toothpaste for initial two months, followed by the use of fluoride toothpaste of the same brand for the next two months. The buccal epithelial cells were sampled at baseline and 30, 60, 90 and 120 days after the beginning of the research. Chromosomal damages were analyzed by micronucleus assay.

Conditions

  • Toxicity

Interventions

OTHER

Toothpaste non-fluoride and fluoride

Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Contemporary, participants did not use other agents for oral hygiene such as mouthwash or topical fluoridation.

Sponsors & Collaborators

  • University of Split, School of Medicine

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-06-15
Completion
2016-07-20

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325400 on ClinicalTrials.gov