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

Phase 1

Recruiting

• Conditions: Adolescent; Sleep Bruxism; Children; Temporomandibular Joint Disorders
• Interventions: Drug: Melissa; Drug: Placebo

• Registration Number: NCT06214637
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-12-12
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-08-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Melissa officinalis 6 CH	Melissa	It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. This concentration 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.
Melissa officinalis 9 CH	Melissa	It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. This concentration 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.
Placebo	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.
Melissa officinalis 12 CH	Melissa	It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. This concentration 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.

Primary Outcome Measures

Name	Time	Method
General objective	Twice a month	Number of participants who had a positive response to the proposed treatment, that is a reduction in bruxism episodes during the sleep period.

Trial Locations

Locations (1)

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil