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NCT03325400
Cytogenetic Damage in Buccal Cells Caused by Toothpaste
NA trial testing Toothpaste non-fluoride and fluoride in Toxicity in 40 participants. Completed in 20 July 2016.
15 June 2016
Quick facts
| Lead sponsor | University of Split, School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 40 |
| Start date | 1 January 2016 |
| Primary completion | 15 June 2016 |
| Estimated completion | 20 July 2016 |
Drugs / interventions tested
- Toothpaste non-fluoride and fluoride
Conditions studied
- Toxicity — all drugs for Toxicity →
Sponsor
University of Split, School of Medicine
Who can join
Eligibility, any sex, with Toxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03325400
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03325400 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Split, School of Medicine
- Last refreshed: 30 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03325400.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing