Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate, through a crossover, controlled, double-blind and randomized clinical trial, the efficacy of Phytolacca decandra in association or not with Melissa officinalis in the treatment of children with nocturnal bruxism. Children from 3 to 12 years old with nocturnal bruxism will be randomly allocated into different groups of treatment stage as follows: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4) Phytolacca decandra associated with Melissa officinalis. All children will participate to each clinical stage, with a period of 14 days of whashout. Children and the principal investigator will be masked to treatment. The efficacy will be evaluated through parents report about the absence of tooth clenching or grinding by children and electromiography exams. The secondary outcomes that will be evaluated are: trait anxiety and quality of life related to oral health.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro

Criteria

Inclusion criteria:

• Children with good general health; children aged 03-12 years old; children with nocturnal bruxism reported by their parents/guardians.

Exclusion criteria:

• Children with special needs (frame psychological, psychiatric and neurological disorders or any systemic commitments)

• Children with carious lesions in dentin

• Children with orthodontic appliances

• Children with dental anomalies

• Children with dental erosions

• Children with the following malocclusions: Class II and III of Angle, crossbite and open bite

• Children that will be in any medication that modify the salivary flow and / or cause alteration of the central nervous system.