Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism: a Controlled and Randomized Clinical Trial

This is a randomized, double-blind, crossover, placebo-controlled study in which children aged 3 to12 years old with nocturnal bruxism will be randomly allocated into different phases of the study, according to treatment step: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4) Phytolacca decandra associated with Melissa officinalis. This study will be enrolled in Dental clinic of the Pediatric Dentistry department of Dental School, in Federal University of Rio de Janeiro (UFRJ), from September 2014 to July 2017. All children will participate of each clinical stages, with a washout interval of 14 days between the phases. Children and the principal investigator will be masked to treatment.

After anamnesis, extra and intraoral clinical examination will be conducted at the beginning of the study, by a single trained and calibrated examiner (the researcher responsible for the study). Thus, facial symmetry, temporomandibular joints and masticatory muscle activity should be observed. For the evaluation of the residual effect of bruxism in the muscles (masseter and temporalis) of the masticatory system, electromyography exams will be performed.

For intra-oral clinical examination, patients will be positioned comfortably in a dental chair and the exam will be conducted with the aid of artificial light from dental reflector mirror plane, exploratory probe and cotton tweezers. Data from each patient will also be recorded in the dental records by a previously trained annotator. The presence of clinical signs related to the presence of bruxism, such as the presence of dental enamel wear and microfractures facets will also be evaluated.

The Brazilian version of ECOHIS (B-ECOHIS) will be used to assess the quality of life for the selected children with 0-7 years old. This instrument will be applied before and after each phase of the study. And, the Brazilian version of "Child Perceptions Questionnaire" (CPQ) 8-10 and 11-14, will also be used to assess the physical and psychosocial impact of nocturnal bruxism in children and adolescents in the study.

The child's anxiety will be observed by means of a rating scale of trait anxiety in children. This scale will also be applied before and after each phase of the study.