Cytogenetic damage induced by toothpastes: what is the best way to evaluate the harmful effects on oral mucosa cells?
Daniel Araki Ribeiro
Received 26 Apr 2019, Accepted 11 May 2019, Published online: 07 Jun 2019
Download citation https://doi.org/10.1080/00016357.2019.1620965
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Translator disclaimer
"Cytogenetic damage induced by toothpastes: what is the best way to evaluate the harmful effects on oral mucosa cells?." Acta Odontologica Scandinavica, ahead-of-print(ahead-of-print), p. 1
Additional information
Acknowledgements
DAR is a researcher on Productivity at CNPq (Conselho Nacional de Desenvolvimento Cientifico e Tecnologico), level 1C.
Disclosure statement
No potential conflict of interest was reported by the author.
Cytogenetic Damage in Buccal Cells Caused by Toothpaste
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03325400
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
University of Split, School of Medicine
Information provided by (Responsible Party):
University of Split, School of Medicine
Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief 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.
Condition or disease Intervention/treatment Phase
Toxicity
Other: Toothpaste non-fluoride and fluoride
Not Applicable
Show Detailed Description
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: In Vivo Comparison of Genotoxic and Cytotoxic Effects of Different Brands of Toothpaste - Without and With Fluoride
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 15, 2016
Actual Study Completion Date : July 20, 2016
Resource links provided by the National Library of Medicine
Drug Information available for: Fluorine Fluoride
U.S. FDA Resources
Arms and Interventions
Go to sections
Arm Intervention/treatment
Non-fluoride toothpaste
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.
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.
Other Name: Sensodyne Classic (GlaxoSmithKline, UK), Sensodyne Fluor (GlaxoSmithKline, UK), Plidenta 15 Seconds (Neva Ltd., Croatia), Plidenta Sensitive (Neva Ltd., Croatia)
Active Comparator: Fluoride toothpaste
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.
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.
Other Name: Sensodyne Classic (GlaxoSmithKline, UK), Sensodyne Fluor (GlaxoSmithKline, UK), Plidenta 15 Seconds (Neva Ltd., Croatia), Plidenta Sensitive (Neva Ltd., Croatia)
Outcome Measures
Go to sections
Primary Outcome Measures :
Cytogenetic damage [ Time Frame: four months ]
The aim of this study was to assess the number of buccal epithelial cells with cytogenetic defects in participants using commercial toothpaste with and without fluoride of the same manufactures and similar composition. Using the micronucleus assay, the effect of toothpaste on the buccal cells was monitored, depending on the time of the exposure.
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
completely healthy (no systemic disorders and diseases)
Exclusion Criteria:
consuming two or more alcohol units for three or more times a week
patients with oral lesions
history of malignancy
patients with removable and fixed prosthodontics, orthodontic appliances.
Contacts and Locations
Go to sections
No Contacts or Locations Provided
More Information
Go to sections
Publications:
Tadin A, Gavic L, Zeravica A, Ugrin K, Galic N, Zeljezic D. Assessment of cytotoxic and genotoxic effects of conventional and whitening kinds of toothpaste on oral mucosa cells. Acta Odontol Scand. 2018 Jan;76(1):64-70. doi: 10.1080/00016357.2017.1384567. Epub 2017 Sep 29.
Responsible Party: University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03325400 History of Changes
Other Study ID Numbers: USplitSM
First Posted: October 30, 2017 Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data from individual respondents will not be available to other researchers
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Split, School of Medicine:
Fluoride toothpaste
Cytogenetic damage
Exfoliated buccal cells
Micronucleus assay
Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Daniel Araki Ribeiro
Received 26 Apr 2019, Accepted 11 May 2019, Published online: 07 Jun 2019
Download citation https://doi.org/10.1080/00016357.2019.1620965
Select Language▼
Translator disclaimer
"Cytogenetic damage induced by toothpastes: what is the best way to evaluate the harmful effects on oral mucosa cells?." Acta Odontologica Scandinavica, ahead-of-print(ahead-of-print), p. 1
Additional information
Acknowledgements
DAR is a researcher on Productivity at CNPq (Conselho Nacional de Desenvolvimento Cientifico e Tecnologico), level 1C.
Disclosure statement
No potential conflict of interest was reported by the author.
Cytogenetic Damage in Buccal Cells Caused by Toothpaste
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03325400
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
University of Split, School of Medicine
Information provided by (Responsible Party):
University of Split, School of Medicine
Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief 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.
Condition or disease Intervention/treatment Phase
Toxicity
Other: Toothpaste non-fluoride and fluoride
Not Applicable
Show Detailed Description
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: In Vivo Comparison of Genotoxic and Cytotoxic Effects of Different Brands of Toothpaste - Without and With Fluoride
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 15, 2016
Actual Study Completion Date : July 20, 2016
Resource links provided by the National Library of Medicine
Drug Information available for: Fluorine Fluoride
U.S. FDA Resources
Arms and Interventions
Go to sections
Arm Intervention/treatment
Non-fluoride toothpaste
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.
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.
Other Name: Sensodyne Classic (GlaxoSmithKline, UK), Sensodyne Fluor (GlaxoSmithKline, UK), Plidenta 15 Seconds (Neva Ltd., Croatia), Plidenta Sensitive (Neva Ltd., Croatia)
Active Comparator: Fluoride toothpaste
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.
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.
Other Name: Sensodyne Classic (GlaxoSmithKline, UK), Sensodyne Fluor (GlaxoSmithKline, UK), Plidenta 15 Seconds (Neva Ltd., Croatia), Plidenta Sensitive (Neva Ltd., Croatia)
Outcome Measures
Go to sections
Primary Outcome Measures :
Cytogenetic damage [ Time Frame: four months ]
The aim of this study was to assess the number of buccal epithelial cells with cytogenetic defects in participants using commercial toothpaste with and without fluoride of the same manufactures and similar composition. Using the micronucleus assay, the effect of toothpaste on the buccal cells was monitored, depending on the time of the exposure.
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
completely healthy (no systemic disorders and diseases)
Exclusion Criteria:
consuming two or more alcohol units for three or more times a week
patients with oral lesions
history of malignancy
patients with removable and fixed prosthodontics, orthodontic appliances.
Contacts and Locations
Go to sections
No Contacts or Locations Provided
More Information
Go to sections
Publications:
Tadin A, Gavic L, Zeravica A, Ugrin K, Galic N, Zeljezic D. Assessment of cytotoxic and genotoxic effects of conventional and whitening kinds of toothpaste on oral mucosa cells. Acta Odontol Scand. 2018 Jan;76(1):64-70. doi: 10.1080/00016357.2017.1384567. Epub 2017 Sep 29.
Responsible Party: University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03325400 History of Changes
Other Study ID Numbers: USplitSM
First Posted: October 30, 2017 Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data from individual respondents will not be available to other researchers
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Split, School of Medicine:
Fluoride toothpaste
Cytogenetic damage
Exfoliated buccal cells
Micronucleus assay
Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
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