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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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
Sponsor: Universidade Federal do Rio de Janeiro

Current Primary Outcome:

• Evaluation of efficacy of Phytolacca decandra in association or not with Melissa officinalis in comparison of placebo in arresting nocturnal bruxism, by the use of a visual analog scale [ Time Frame: During the period of treatments and washout : 168 days ]
  Parents / guardians will be asked to schedule a graduated visual analog scale from 0 to 10 to determine bruxism level (absence or not of tooth clenching or grinding) of your child during the 30 days of each medicine usage and also during the washout period.
• Evaluation of the efficacy of Phytolacca decandra in association or not with Melissa officinalis in comparison of placebo in arresting nocturnal bruxism, by the electromiography analysis [ Time Frame: Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days ]
  All children will be submitted to eletromiography analysys to measure the masseter and temporalis muscles forces before and after each tretament stage.

Original Primary Outcome: Same as current

Current Secondary Outcome: Identify changes in the quality of life children with bruxism before and after treatments by the use of B-ECOHIS and PCP-Q questionaries [ Time Frame: Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days ]

Original Secondary Outcome: Same as current

Information By: Universidade Federal do Rio de Janeiro

Dates:
Date Received: July 28, 2016
Date Started: September 2014
Date Completion: July 2017
Last Updated: August 12, 2016
Last Verified: August 2016