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NCT04540991
Genotoxicity Assessment of Dental Implants in Gingival Epithelial Cells
Phase 3 trial testing implant placement in Genotoxicity in 80 participants. Status unknown.
20 March 2021
Quick facts
| Lead sponsor | Daniel Jerković |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | screening |
| Enrollment | 80 |
| Start date | 10 March 2020 |
| Primary completion | 20 March 2021 |
| Estimated completion | 25 April 2022 |
| Sites | 1 location across Croatia |
Drugs / interventions tested
- implant placement
- gingiva former placement
- Collecting gingival epithelial cellsusing the swab technique
Conditions studied
- Genotoxicity — all drugs for Genotoxicity →
Sponsor
Daniel Jerković
Who can join
18 and older, any sex, with Genotoxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Due to the strong correlation between genotoxicity and carcinogenesis, it is necessary to clarify the potential genotoxic effects of titanium dental implant systems. As most dental materials release small amounts of several elements into the oral cavity, proper regulations have to guarantee that the concern from genotoxicity/mutagenicity of dental materials is annulated or at the lowest possible level. Thus, further biocompatibility records are needed in order to evaluate the comprehensive risks of these compounds. In a view of the above-mentioned data, the aim of this in vivo study is to evaluate genotoxic and cytotoxic potential of implants and gingiva formers from two different implant systems in gingival epithelial cells. Exfoliated gingival cells will be taken from 80 participants before and after 90 days of dental implant insertion, and 21 days following gingiva former placement. DNA damage will be analyzed using the micronucleus test. Tested dental implants will be Ankylos and Dentium, with corresponding gingival former.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04540991
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Related trials
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Other recruiting trials for Genotoxicity
Currently open trials in the same condition.
- NCT06999785 — Assessment of the Impact of Increased Production of Reactive Oxygen Species Produced During Repeated Sessions of Hyperba · NA · recruiting
Other Daniel Jerković trials
Trials by the same sponsor.
- NCT03398382 — Effect of Oral Magnesium on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars. · Phase 1, PHASE2 · unknown
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 NCT04540991 (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 Daniel Jerković
- Last refreshed: 7 September 2020
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/NCT04540991.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing