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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06214637
Other study ID # 69209423.4.0000.0268
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2023
Est. completion date September 30, 2024

Study information

Verified date January 2024
Source Universidade Federal do Rio de Janeiro
Contact Larissa Silva, Phd student
Phone +55 21 3938-2101
Email lara_soares_14@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 with probable sleep bruxism. Methodology: This is a randomized, triple-blind, crossover, and placebo-controlled clinical trial. The research participants will be children aged 5 to 10 years old and adolescents aged 11 to 16 years old who attend dental treatment at the FO/UFRJ Pediatric Dentistry Clinics. After approval by the Human Research Ethics Committee, children and adolescents will undergo homeopathic treatment with Melissa officinalis in different concentrations for possible sleep bruxism. In addition, research participants will undergo an assessment of TMJ, sleep, circadian cycle, quality of life, and quality of life related to oral health. The data will be tabulated and analyzed according to sex, age group, presence of possible sleep bruxism, presence or absence of TMD, circadian characteristics, presence or absence of sleep disorders, daytime and nighttime behavioral characteristics. The data will be tabulated and evaluated using SPSS 21.0. Absolute and relative frequency, odds ratio, correlation analysis and other relevant analyzes and statistical tests (p<0.05) will be carried out in accordance with the objectives proposed by the study


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date September 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 16 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Melissa
The test solutions will be administered once a day through administration in drops for children between 5 and 10 years old and for adolescents between 11 and 16 years old. As participants will be between 5 and 16 years old, children will be given a minimum of 5 and a maximum of 10 drops of the solutions per individual (Tavares-Silva, Holandino et al. 2019) as well as a maximum of 10 drops for adolescents of solutions per individual (Taylor, Lancaster et al. 2000). Highlighting that the prescription of Melissa officinalis will be at night, around 20/30 minutes before bedtime, respecting the indications for the medications described in the Hahnemannian Materia Medica (Vijnovsky, 2003). All medications must be taken away from meals and they will be instructed not to use mentholated substances, respecting a minimum time of 30 minutes.
Placebo
It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. The placebo, a drug without active substance, that will be administered to research participants will be the biotherapeutic vehicle, that is, 30% alcohol (v/v), which is commonly used as a vehicle for homeopathic medicines.

Locations

Country Name City State
Brazil Universidade Federal do Rio de Janeiro Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary General objective Number of participants who had a positive response to the proposed treatment, that is a reduction in bruxism episodes during the sleep period. Twice a month
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