Last reviewed · How we verify
NCT05821712
A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems
Phase 3 trial testing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash in Plaque in 80 participants. Completed in 24 September 2021.
24 September 2021
Quick facts
| Lead sponsor | Colgate Palmolive |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 8 March 2021 |
| Primary completion | 24 September 2021 |
| Estimated completion | 24 September 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash — full drug profile →
- 0.057% sodium fluoride Mouthwash — full drug profile →
Conditions studied
- Plaque — all drugs for Plaque →
- Gum Disease — all drugs for Gum Disease →
Sponsor
Colgate Palmolive — full company profile →
Who can join
Adults 18 to 70, any sex, with Plaque or Gum Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057% sodium fluoride after 3 and 6 months of product use.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial.
Montesani L, Montesani L, Mateo L, Daep C, et al · · 2024 · cited 4× · PMID 38217757 · DOI 10.1007/s00784-023-05487-0
Verify or expand the search:
- PubMed search for NCT05821712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Plaque
Currently open trials in the same condition.
- NCT07501455 — Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolera · NA · recruiting
- NCT07398846 — Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reduci · Phase 3 · recruiting
- NCT06939374 — Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditi · NA · recruiting
Other Colgate Palmolive trials
Trials by the same sponsor.
- NCT07398846 — Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reduci · Phase 3 · recruiting
- NCT07276672 — Efficacy of a Toothpaste Containing Hydrogen Peroxide as Compared to a Regular Fluoride Toothpaste Without Hydrogen Pero · Phase 3 · completed
- NCT07225478 — Clinical Study to Evaluate the Tooth Whitening Efficacy of a New NextGen In-office Whitening System · Phase 3 · completed
- NCT07224828 — The Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis · Phase 3 · completed
- NCT07134231 — Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model · Phase 3 · completed
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 NCT05821712 (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 Colgate Palmolive
- Last refreshed: 20 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/NCT05821712.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing