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

NCT02870543 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-08-17

No results posted yet for this study

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.

Conditions

  • Nocturnal Bruxism

Interventions

DRUG

Phytolacca decandra

Treatment of bruxism

DRUG

Melissa officinalis

Treatment of bruxism

DRUG

Phyt.decandra + Melissa offic.

Treatment of bruxism

Sponsors & Collaborators

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Andrea G. Antonio, Adjunct Professor · Universidade Federal do Rio de Janeiro

  • Lucianne Cople Maia, Full Professor · Universidade Federal do Rio de Janeiro

  • Cláudia Tavares, Ph.D student · Universidade Federal do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-07-31
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870543 on ClinicalTrials.gov