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

Universidade Federal do Rio de Janeiro

Status and phase: Enrolling; Phase 1

Conditions: Temporomandibular Joint Disorders; Children; Sleep Bruxism; Adolescent

Treatments: Drug: Placebo; Drug: Melissa

Study type: Interventional

Funder types: Other

Identifiers

NCT06214637

69209423.4.0000.0268

Details and patient eligibility

About

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

Enrollment: 42 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Melissa officinalis 6 CH

Experimental group

Description:

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.

Treatment:

Drug: Melissa

Melissa officinalis 9 CH

Experimental group

Description:

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.

Treatment:

Drug: Melissa

Melissa officinalis 12 CH

Experimental group

Description:

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.

Treatment:

Drug: Melissa