Effect of herbal toothpaste versus conventional one on black stains in a group of Egyptian children: a randomized controlled study

Abstract To determine the recurrence rate of Black Stain (BS) in children using herbal versus fluoridated toothpaste formulations, in terms of stain recurrence, stain score, and parental satisfaction. Twenty- eight children with BS were randomly allocated into two groups: Control group I received a fluoridated toothpaste (Signal Cavity Fighter™), and experimental group II received an herbal toothpaste (Dabur Red™). Following dental polishing and salivary sample collection, the levels of four bacterial species— Streptococcus mutans (SM), Lactobacillus casei (LB), Actinomyces naeslundii (AC), and Prevotella melaninogenica (PM), were measured utilizing quantitative real-time polymerase chain reaction (qPCR). Both groups were evaluated for changes in stain score, percentage reduction in bacterial load, and degree of parental satisfaction. After 6 months, 85.7% of participants in the herbal group were significantly free from stain recurrence (p = 0.013, ω = 0.53; large effect size), achieved a stain score of 0 (p = 0.004, ω = 0.38; small effect size), and reported a satisfaction score of 5 (p = 0.008, δ = − 0.51; large effect size) compared with the control group. With regard to bacterial counts, the reduction in SM was significantly greater in the control group, whereas reductions in the other bacterial species were significantly greater in the herbal group, all with large effect sizes. Within the limitations of this study, herbal toothpaste may demonstrate promising efficacy in stain removal in terms of improving parental satisfaction, reducing stain recurrence and all included bacteria except SM in comparison to the control group. Trial registration: This study was registered retrospectively on Clinical Trials. gov on 03/06/2025 as first posted date before any outcome assessment; ID: NCT06872827; https://clinicaltrials.gov/study/NCT06872827 .