Abstract
BACKGROUND: Oral health education in childhood plays a pivotal role in preventing dental diseases; however, conventional teaching methods often fail to engage young learners. In addition, despite encouraging results, many existing gamified oral health applications lack theoretical foundations, usability testing, and clinical evaluation. This study therefore evaluated the effectiveness of Happy Teeth, a gamified digital application, in enhancing oral health knowledge, behaviors, and clinical outcomes among school-aged children, compared with traditional education alone. METHODS: A single-blind, controlled clinical trial was conducted among 8-9-year-old students from four elementary schools in Isfahan, Iran. Participants were randomly assigned to intervention and control groups. Both received one session of standard oral health education, while the intervention group additionally used the Happy Teeth game-developed in Unity-over a 3-4-week period. The game integrated interactive mini-games, quizzes, and a tower-defense strategy aligned with oral health behaviors. Outcomes assessed at baseline and three months post-intervention included oral health knowledge (13-item questionnaire), plaque index (Quigley-Hein), dietary behavior scores, and self-reported oral hygiene practices. RESULTS: A total of 108 children participated. Knowledge scores improved significantly in the intervention group (p = 0.008), particularly among boys (p = 0.01). Both groups exhibited reductions in plaque index, though the between-group difference was not statistically significant (p = 0.08). Dietary behavior improved in the intervention group (p = 0.01), but no significant difference emerged between groups. Brushing frequency remained unchanged. Children's satisfaction with the game was high-87% enjoyed it-and 68% of parents said they would recommend it to others. CONCLUSION: The Happy Teeth gamified application effectively enhanced oral health knowledge and dietary awareness among children but demonstrated limited influence on clinical and behavioral outcomes such as plaque reduction and brushing frequency. Gamification appears to be a promising adjunct to traditional oral health education, warranting further research with longer follow-up periods and more advanced interactive features.