DNA DamageNCT04801576
In Vivo Assessment of Geno- and Cytotoxicity of Fluoridated Toothpastes and Mouthrinses on Buccal Epithelial Cells
A study testing Flouride in mouthrinses in people with DNA Damage, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
Buccal cells represent the first barrier to the oral hygiene products' potential toxic effect. The usual concentration of fluoride in toothpastes is 1000/1100 parts per million (ppm F); toothpastes with higher (1500 ppm F) and lower than conventional fluoride levels (around 500 ppm F) are available in many countries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Damage
- What is being tested?
- Flouride in mouthrinses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- a sufficient level of education to understand the procedures
- patients not younger than 18 and not older than 65 years
- non-smokers
- patients without exposure to any x-ray examination in last 6 months
Who cannot join
- subjects with use of any medications
- subjects that use alcohol
- subjects with oral lesions
- subjects with history of chronic health conditions
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of medicine
Split, 21000
Ema Puizina Mladinić, M.D., 0955749644, e.puizina@gmail.com
About this study
Official title: In Vivo Assessment of Geno- and Cytotoxicity of Fluoridated Toothpastes and Mouthrinses on Human Buccal Epithelial Cells
Buccal cells represent the first barrier to the oral hygiene products' potential toxic effect. The usual concentration of fluoride in toothpastes is 1000/1100 parts per million (ppm F); toothpastes with higher (1500 ppm F) and lower than conventional fluoride levels (around 500 ppm F) are available in many countries. Toothpastes containing higher concentrations of fluoride confer greater protection against caries but at the same time the fluoride is able to induce harmful effects on oral mucosa cells.
The study would include around 40 participants, aged between 20 and 65, divided in two groups. Each group will use fluoride free toothpaste for 28 days, than afterwards group B will get toothpastes (each for 28 days) with no fluoride, 1045 ppm F and 1450 ppm F used together with mouthrinse containing 450 ppm F, while the group A will have everything the same except the mouthrinse that will contain no fluoride - a placebo mouthrinse.
Read more
Every 28 days buccal cells samples would be collected from each participant and a Buccal micronucleus cytome assay would be performed according to Nature protocols: Thomas et all.
The aim of this study would be to assess the possible cumulative effect of together use of fluoridated toothpastes and mouthrinses, since population worldwide uses them together without any exact studies about toxicity.
- Conditions
- DNA Damage
- Being tested
- Flouride in mouthrinses, Placebo mouthrinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flouride in mouthrinsesOther
Custom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations.
Placebo mouthrinseOther
Mouthrinses without flouride
| Study group | Role | What they receive |
|---|---|---|
| Placebo mouthrinse | Placebo comparator | Group that uses just toothpaste without fluoride for 28 days; toothpaste without flouride and mouthrinse without flouride for 28 days; toothpaste with 1050 ppm F and mouthrinse without flouride for 28 days; toothpaste with 1450 ppm F and mouthrinse without flouride for 28 days. Receives: Other: Placebo mouthrinse |
| Fluoride in mouthrinses | Experimental | Group that uses just toothpaste without fluoride for 28 days; toothpaste without flouride and mouthrinse with 450 ppm F for 28 days; toothpaste with 1050 ppm F and mouthrinse with 450 ppm F for 28 days; toothpaste with 1450 ppm F and mouthrinse with 450 ppm F for 28 days. Receives: Other: Flouride in mouthrinses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related cytotoxic and genotoxic events in buccal cells assessed by buccal cytome micronucleus assay.
Method used is Buccal Micronucleus Cytome (BMCyt) assay as minimally invasive method for studying DNA damage, chromosomal instability, cell death and the regenerative potential of human buccal mucosal tissue. This is one of the current established methods for buccal cell collection using a small-headed toothbrush, the generation of a single-cell suspension, slide preparation using cytocentrifugation, fixation and staining using Feulgen and Light Green for both bright field and fluorescence microscopic analysis.
Measured: 112 days (4 periods of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2021
- Primary completion21 Feb 2021
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DNA DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ema Puizina Mladinić, MD, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801576
- Sponsor's protocol ID
- EPuizina
- Status last verified
- Jan 2022
- First submitted
- 23 Feb 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tadin A, Gavic L, Govic T, Galic N, Zorica Vladislavic N, Zeljezic D. In vivo evaluation of fluoride and sodium lauryl sulphate in toothpaste on buccal epithelial cells toxicity. Acta Odontol Scand. 2019 Jul;77(5):386-393. doi: 10.1080/00016357.2019.1577988. Epub 2019 Feb 20.
PubMed 30784350Tadin 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.
PubMed 28959909Tadin A, Marovic D, Galic N, Kovacic I, Zeljezic D. Composite-induced toxicity in human gingival and pulp fibroblast cells. Acta Odontol Scand. 2014 May;72(4):304-11. doi: 10.3109/00016357.2013.824607. Epub 2013 Aug 22.
PubMed 23964631Ribeiro DA, Cardoso CM, Yujra VQ, DE Barros Viana M, Aguiar O Jr, Pisani LP, Oshima CTF. Fluoride Induces Apoptosis in Mammalian Cells: In Vitro and In Vivo Studies. Anticancer Res. 2017 Sep;37(9):4767-4777. doi: 10.21873/anticanres.11883.
PubMed 28870895Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7.
PubMed 19444240
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Assessment of Geno- and Cytotoxicity of Fluoridated Toothpastes and Mouthrinses on Human Buccal Epithelial Cells
- ClinicalTrials.gov ID
- NCT04801576
- Acronym / sponsor ID
- EPuizina
- Conditions
- DNA Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Buccal cells represent the first barrier to the oral hygiene products' potential toxic effect. The usual concentration of fluoride in toothpastes is 1000/1100 parts per million (ppm F); toothpastes with higher (1500 ppm F) and lower than conventional fluoride levels (around 500 ppm F) are available in many countries. Toothpastes containing higher concentrations of fluoride confer greater protection against caries but at the same time the fluoride is able to induce harmful effects on oral mucosa cells.
The study would include around 40 participants, aged between 20 and 65, divided in two groups. Each group will use fluoride free toothpaste for 28 days, than afterwards group B will get toothpastes (each for 28 days) with no fluoride, 1045 ppm F and 1450 ppm F used together with mouthrinse containing 450 ppm F, while the group A will have everything the same except the mouthrinse that will contain no fluoride - a placebo mouthrinse.
Every 28 days buccal cells samples would be collected from each participant and a Buccal micronucleus cytome assay would be performed according to Nature protocols: Thomas et all.
The aim of this study would be to assess the possible cumulative effect of together use of fluoridated toothpastes and mouthrinses, since population worldwide uses them together without any exact studies about toxicity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo mouthrinse | Placebo comparator | Other: Placebo mouthrinseGroup that uses just toothpaste without fluoride for 28 days; toothpaste without flouride and mouthrinse without flouride for 28 days; toothpaste with 1050 ppm F and mouthrinse without flouride for 28 days; toothpaste with 1450 ppm F and mouthrinse without flouride for 28 days. |
| Fluoride in mouthrinses | Experimental | Other: Flouride in mouthrinsesGroup that uses just toothpaste without fluoride for 28 days; toothpaste without flouride and mouthrinse with 450 ppm F for 28 days; toothpaste with 1050 ppm F and mouthrinse with 450 ppm F for 28 days; toothpaste with 1450 ppm F and mouthrinse with 450 ppm F for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy subjects
- a sufficient level of education to understand the procedures
- patients not younger than 18 and not older than 65 years
- non-smokers
- patients without exposure to any x-ray examination in last 6 months
Key exclusion criteria (4 listed)
- subjects with use of any medications
- subjects that use alcohol
- subjects with oral lesions
- subjects with history of chronic health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flouride in mouthrinsesCustom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations. | Other | Fluoride in mouthrinses |
| Placebo mouthrinseMouthrinses without flouride | Other | Placebo mouthrinse |
Primary outcome
Number of patients with treatment-related cytotoxic and genotoxic events in buccal cells assessed by buccal cytome micronucleus assay.
Time frame: 112 days (4 periods of 28 days)
Method used is Buccal Micronucleus Cytome (BMCyt) assay as minimally invasive method for studying DNA damage, chromosomal instability, cell death and the regenerative potential of human buccal mucosal tissue. This is one of the current established methods for buccal cell collection using a small-headed toothbrush, the generation of a single-cell suspension, slide preparation using cytocentrifugation, fixation and staining using Feulgen and Light Green for both bright field and fluorescence microscopic analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 30784350Tadin A, Gavic L, Govic T, Galic N, Zorica Vladislavic N, Zeljezic D. In vivo evaluation of fluoride and sodium lauryl sulphate in toothpaste on buccal epithelial cells toxicity. Acta Odontol Scand. 2019 Jul;77(5):386-393. doi: 10.1080/00016357.2019.1577988. Epub 2019 Feb 20.
- Results publication: PubMed 28959909Tadin 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.
- Results publication: PubMed 23964631Tadin A, Marovic D, Galic N, Kovacic I, Zeljezic D. Composite-induced toxicity in human gingival and pulp fibroblast cells. Acta Odontol Scand. 2014 May;72(4):304-11. doi: 10.3109/00016357.2013.824607. Epub 2013 Aug 22.
- Results publication: PubMed 28870895Ribeiro DA, Cardoso CM, Yujra VQ, DE Barros Viana M, Aguiar O Jr, Pisani LP, Oshima CTF. Fluoride Induces Apoptosis in Mammalian Cells: In Vitro and In Vivo Studies. Anticancer Res. 2017 Sep;37(9):4767-4777. doi: 10.21873/anticanres.11883.
- Results publication: PubMed 19444240Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flouride in mouthrinses in people with DNA Damage, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ema Puizina Mladinić, M.D. (00385955749644, e.puizina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment-related cytotoxic and genotoxic events in buccal cells assessed by buccal cytome micronucleus assay. (time frame: 112 days (4 periods of 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801576, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.