Seriwatanachai D.Triratana T.Kraivaphan P.Huber N.Poth T.Mateo L.R.Stellitano M.Zhang Y.P.Mahidol University2025-02-272025-02-272025-12-01BMC Oral Health Vol.25 No.1 (2025)https://repository.li.mahidol.ac.th/handle/20.500.14594/105470Objectives: To evaluate the efficacy of a toothpaste containing amine compound, 0.5% zinc lactate, and 1400 ppm F (NaF) in comparison to a regular fluoride toothpaste containing 1450 ppm F as MFP/NaF (negative control). Plaque and gingivitis indices were determined over a 6-month period. Materials and methods: In a randomized, double-blind, two-cell, parallel-group design on healthy adults from the Bangkok, Thailand area presenting with initial gingivitis (Löe-Silness gingival index ≥ 1) and visible plaque (Turesky Modification-Quigley-Hein index ≥ 1.5) were assigned test and negative control toothpastes and instructed to brush twice daily for two minutes. Results: Site-level (N = 10,778) and subject-level (N = 92) data indicated that the test toothpaste increased the number of healthy sites and improved gum health as compared to the negative control toothpaste. For the test group, after 6 months, the average reduction for plaque, gingival index, and gingival severity was 31.2%, 32.3%, and 49.3%, respectively. Average reductions were greater in the test group than the negative control group across all measures. Conclusions: The amine + zinc + fluoride toothpaste significantly improved measures of plaque (12× more effective) and gingivitis (5× more effective) in comparison to a standard fluoride toothpaste, suggesting that the novel formulation with antibacterial active ingredients amine and zinc facilitates more effective plaque removal, and promotes gingival health. Clinical relevance: These results suggest that daily use of amine + zinc + fluoride toothpaste can provide a significant improvement in managing plaque accumulation and bleeding associated with gingival inflammation especially for patients experiencing gingivitis. Clinical trial registration: NCT06563518 (registration date: August 19, 2024).DentistryArticleSCOPUS10.1186/s12903-025-05551-z2-s2.0-852181555171472683139910536