Using Melissa Officinalis to Treat Sleep Bruxism in Kids and Teens
Effectiveness of Melissa Officinalis in Various Concentrations for the Treatment of Probable Sleep Bruxism in Children and Adolescents: Controlled and Randomized Clinical Trial
This study tests if a herbal treatment called Melissa officinalis can help kids and teens aged 5 to 16 who grind their teeth at night feel better and improve their sleep.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | Universidade Federal do Rio de Janeiro Academic / other |
| Locations | 1 site (Rio de Janeiro) |
| Trial ID | NCT06214637 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Melissa officinalis in various concentrations for treating probable sleep bruxism in children and adolescents aged 5 to 16 years. The study employs a randomized, triple-blind, crossover, and placebo-controlled design, ensuring rigorous assessment of the treatment's efficacy. Participants will receive homeopathic treatment while undergoing evaluations related to temporomandibular joint (TMJ) health, sleep patterns, and overall quality of life. Data will be analyzed based on age, sex, and presence of sleep bruxism or TMJ disorders.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 5 to 16 years with probable sleep bruxism.
Not a fit: Patients with special needs, severe dental anomalies, or those using orthodontic appliances may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a natural and effective option for managing sleep bruxism in children and adolescents.
How similar studies have performed: While the use of Melissa officinalis in this context is relatively novel, other studies have explored herbal treatments for similar conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 5 to 16 years; * Patients with complete primary dentition, mixed or secondary dentition; * Patients with probable sleep bruxism. Exclusion Criteria: * Patients with special needs (psychological, psychiatric and neurological, diagnosed with anxiety disorder or any systemic impairment); * Patients with parafunctional habits (finger sucking and/or pacifier, onychophagia, biting objects, etc.) * Patients with caries lesions in dentin in one or more elements (ICDAS values 4, 5 and 6); * Patients affected by molar-incisor hypomineralization (MIH) * Patients with dental anomalies such as dentinogenesis imperfecta, amelogenesis imperfecta, dysplasia dentin, hypoplasia, and enamel hypocalcification; * Patients with severe malocclusions: Class II and III or crossbite and open bite type; * Patients using orthodontic appliances; * Patients who are taking medications for anxiety disorders or any other that cause alterations in the central nervous system or that alter salivary flow.
Where this trial is running
Rio de Janeiro
- Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Study coordinator: Larissa Silva, Phd student
- Email: lara_soares_14@hotmail.com
- Phone: +55 21 3938-2101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.