Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism
1 other identifier
interventional
52
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2014
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 17, 2016
August 1, 2016
1.8 years
July 28, 2016
August 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
During the period of treatments and washout : 168 days
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
All children will be submitted to eletromiography analysys to measure the masseter and temporalis muscles forces before and after each tretament stage.
Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days
Secondary Outcomes (1)
Identify changes in the quality of life children with bruxism before and after treatments by the use of B-ECOHIS and PCP-Q questionaries
Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days
Other Outcomes (1)
Identify changes in the trait anxiety of children with bruxism before and after treatments by the use of the Brazilian validated version of the Trait-anxiety Scale
Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo
Phytolacca decandra
ACTIVE COMPARATORThe Phytolacca decandra with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.
Melissa officinalis
ACTIVE COMPARATORThe Melissa officinalis with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.
Phyt.decandra + Melissa offic.
EXPERIMENTALThe combination of Phytolacca decandra with Melissa offcicinalis with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.
Interventions
Treatment of bruxism
Treatment of bruxism
Treatment of bruxism
Eligibility Criteria
You may qualify if:
- Children with good general health; children aged 03-12 years old; children with nocturnal bruxism reported by their parents/guardians.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrea G. Antonio, Adjunct Professor
Universidade Federal do Rio de Janeiro
- STUDY DIRECTOR
Lucianne Cople Maia, Full Professor
Universidade Federal do Rio de Janeiro
- PRINCIPAL INVESTIGATOR
Cláudia Tavares, Ph.D student
Universidade Federal do Rio de Janeiro
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D student
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 17, 2016
Study Start
September 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2017
Last Updated
August 17, 2016
Record last verified: 2016-08