UnknownPhase 3

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

52 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range

3 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days

Trial details

NCT IDNCT02870543

SponsorUniversidade Federal do Rio de Janeiro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

View on ClinicalTrials.gov More Nocturnal Bruxism trials