Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801576
Status:
UNKNOWN
Last Update Posted:
2022-01-28
First Post:
2021-02-23
Brief Title:
In Vivo Assessment of Geno- and Cytotoxicity of Fluoridated Toothpastes and Mouthrinses on Buccal Epithelial Cells
Sponsor:
University of Split School of Medicine
Organization:
University of Split School of Medicine
Study Overview
Official Title:
In Vivo Assessment of Geno- and Cytotoxicity of Fluoridated Toothpastes and Mouthrinses on Human Buccal Epithelial Cells
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Buccal cells represent the first barrier to the oral hygiene products potential toxic effect The usual concentration of fluoride in toothpastes is 10001100 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None