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Search / Trial NCT06214637

Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents

Launched by UNIVERSIDADE FEDERAL DO RIO DE JANEIRO · Jan 10, 2024

Trial Information

Current as of June 12, 2025

Recruiting

Keywords

Sleep Bruxism Homeopathy Adolescent Children

ClinConnect Summary

This clinical trial is studying the effectiveness of a natural treatment called Melissa officinalis, or lemon balm, to help children and teenagers who experience sleep bruxism, which is the grinding or clenching of teeth during sleep. The trial will include children aged 5 to 10 years and adolescents aged 11 to 16 years who visit specific dental clinics. Participants will receive different concentrations of Melissa officinalis to see if it helps reduce their bruxism symptoms. Throughout the study, researchers will also assess other factors like sleep quality and jaw health.

To be eligible for the trial, participants must be between 5 and 16 years old and have signs of sleep bruxism. However, children with certain conditions, such as severe dental issues or those who have special needs, will not be included in the study. If your child participates, they can expect to take part in a home-based treatment while researchers collect information to evaluate how well the treatment works. The trial is currently recruiting participants and aims to provide important insights into a natural approach for managing sleep bruxism in young people.

Gender

ALL

Eligibility 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.

About Universidade Federal Do Rio De Janeiro

The Universidade Federal do Rio de Janeiro (UFRJ) is a prestigious higher education institution located in Brazil, renowned for its commitment to academic excellence and research innovation. As a leading sponsor of clinical trials, UFRJ leverages its extensive resources and multidisciplinary expertise to advance medical knowledge and improve patient outcomes. The university fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring rigorous adherence to ethical standards and regulatory compliance. UFRJ is dedicated to contributing to the global scientific community through the development and implementation of cutting-edge clinical research initiatives.

Locations

Rio De Janeiro, , Brazil

Patients applied

0 patients applied

Trial Officials

Lucianne Cople Maia, Phd

Study Director

Universidade Federal do Rio de Janeiro

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported