Status:
RECRUITING
Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Conditions:
Sleep Bruxism
Adolescent
Eligibility:
All Genders
5-16 years
Phase:
PHASE1
Brief Summary
Objective: To investigate, through a controlled and randomized clinical trial, the effectiveness of using Melissa officinalis in different concentrations in the treatment of children and adolescents w...
Eligibility Criteria
Inclusion
- Patients aged 5 to 16 years;
- Patients with complete primary dentition, mixed or secondary dentition;
- Patients with probable sleep bruxism.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06214637
Start Date
August 1 2023
End Date
September 30 2024
Last Update
January 19 2024
Active Locations (1)
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1
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 21941-971