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NCT05594134
Efficacy of an Automatic Toothbrush
NA trial testing Automatic toothbrush with nylon bristle in Dental Plaque in 25 participants. Completed in 21 December 2022.
21 December 2022
Quick facts
| Lead sponsor | University of Florence |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 7 November 2022 |
| Primary completion | 21 December 2022 |
| Estimated completion | 21 December 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Automatic toothbrush with nylon bristle
- Automatic toothbrush with silicone bristle
- Manual toothbrush used for 2 minutes
- Manual toothbrush used for 45 seconds
Conditions studied
- Dental Plaque — all drugs for Dental Plaque →
Sponsor
University of Florence
Who can join
Adults 18 to 30, any sex, with Dental Plaque. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students. Primary endpoint: difference in "full mouth plaque score" between before and after brushing. Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth. Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy of an automatic electric toothbrush with nylon bristles in dental plaque removal: a cross-over randomized controlled trial.
Statie MD, Lomonaco I, Nieri M, Giuntini V, et al · · 2024 · cited 5× · PMID 38480601 · DOI 10.1007/s00784-024-05601-w
Verify or expand the search:
- PubMed search for NCT05594134
- 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 NCT05594134 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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 Florence
- Last refreshed: 18 April 2023
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/NCT05594134.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing