Effect of Mouth Spray Enriched With Salivary Enzymes on the Oral HealthStatus among Young Children - A Randomized Controlled Trial

Objective: This study aimed to evaluate the effectiveness of enzyme based oral spray (Oral7®) as adjunctto routine oral hygiene practice among children aged 4-7 years.Methods: A randomized, double-blind, placebo-controlled trial was conducted. Fifty-two young children with dental caries were randomly assigned to receive either the Oral7® mouth spray (or a placebo in addition to standard oral hygiene care. Plaque and gingivitis scores, as well as salivary bacterial counts, were measured at baseline and after a 4-week follow-up. Plaque levels were assessed using the Silness & Loe (1964) index, and gingivitis was evaluated using the Loe & Silness (1963) index. For salivary bacterial analysis, un-stimulated saliva samples were collected, serially diluted, and cultured on Mitis Salivarius Bacitracin agar to isolate Streptococcus species, followed by bacterial colony counting.Results: The intervention group showed a significant reduction in mean plaque and gingivitis scores with standard deviation from 0.758±0.355 to 0.304±0.318 and from 0.319±0.294 to 0.065±0.185 with p=0.001 at baseline and follow-up respectively. In the control group, the mean plaque scores showed significant reduction from 0.758±0.379 to 0.631±0.381with (p=0.001), while there is no significant change for the mean gingivitis scores from baseline [0.469±0.345] and after 4-weeks [0.431±0.369] with p=0.153. The mean salivary bacterial values in the intervention group significantly decreased (p=0.026), while no significant change was observed in the control group (p=0.284).Conclusion: Maintaining optimal oral hygiene in young children is challenging due to their developing dexterity and need for consistent parental supervision. Mechanical plaque removal through brushing, while effective, is often insufficient, leading to the exploration of chemical plaque control methods like mouthwashes and sprays. The Oral7® mouth spray, provides adjunctive effect to standard oral hygiene practices among young children suggesting it to be a valuable addition to paediatric oral care, potentially preventing dental caries and gingiviti