Effectiveness of a novel amine + zinc + fluoride toothpaste in reducing plaque and gingivitis: results of a six-month randomized controlled trial

• Published in: BMC oral health Vol. 25; no. 1; pp. 188 - 10
• Main Authors: Seriwatanachai, Dutmanee, Triratana, Terdphong, Kraivaphan, Petcharat, Huber, Norbert, Poth, Tilo, Mateo, Luis R., Stellitano, Melissa, Zhang, Yun-Po
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 05.02.2025; BioMed Central; BMC
• Subjects: Adult; Adults; Amine; Amines; Amines - therapeutic use; Antimicrobial agents; Biofilms; Care and treatment; Clinical medicine; Clinical trials; Composition; Dental plaque; Dental Plaque - prevention & control; Dental Plaque Index; Dentifrices; Double-Blind Method; Estimates; Female; Fluoride; Fluoride treatments; Fluorides; Fluorides - therapeutic use; Gingiva; Gingival index; Gingivitis; Gingivitis - prevention & control; Gum disease; Gum diseases; Humans; Inflammation; Male; Middle Aged; Patients; Periodontal Index; Periodontics; Sodium Fluoride - therapeutic use; Substance abuse treatment; Teeth; Testing; Toiletries industry; Toothpaste; Toothpastes - chemistry; Toothpastes - therapeutic use; Treatment Outcome; Young Adult; Zinc; Zinc - therapeutic use; Zinc Compounds - therapeutic use; Thailand; United Kingdom; Bangkok Thailand; Dental plaque; Toothpaste; Amine; Fluoride; Gingivitis
• ISSN: 1472-6831; 1472-6831
• DOI: 10.1186/s12903-025-05551-z

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. 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. 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. 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. 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. NCT06563518 (registration date: August 19, 2024).