Development of an RCT Methodology to Evaluate the Efficacy of Melissa Officinalis at Various Concentrations in Managing Probable Sleep Bruxism: Part 1.

Sleep bruxism is an involuntary jaw movement controlled by the Central Nervous System, and there is no gold standard treatment for it in the literature. Therefore, we developed a methodology in 2019 using homeopathic medications: Melissa officinalis 12 cH (MO) and Phytolacca decandra 12cH (PD), as well as a placebo [1]. The results showed that MO presented better outcomes compared to PD and the placebo. Given these promising findings and after approval from the Research Ethics Committee of the Faculty of Dentistry at the Universidade Federal do Rio de Janeiro, Brazil, under protocol number 5.933.399 (trial registration no. NCT 06214637), this research is undergoing to evaluate the therapeutic potential of Melissa officinalis in different homeopathic centesimal potencies for the treatment of probable sleep bruxism in children aged 5–10 years, using a randomized, triple-blind, placebo-controlled crossover trial methodology. Participants, recruited from the FO/UFRJ Pediatric Dentistry Clinics, are undergoing homeopathic interventions with Melissa officinalis at 6cH, 9cH, and 12cH potencies, as well as a placebo, to assess the efficacy against sleep bruxism. The study also includes evaluations of TMJ health, sleep quality, circadian rhythm, and oral health-related quality of life. The results of this study are currently under evaluation using SPSS 21.0 (p < 0.05) to explore the behavior, correlations, associations, and effectiveness of Melissa officinalis homeopathic medications at each potency in relation to the studied variables.