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

Children Clinical Trial

Official title:

Effectiveness of Melissa Officinalis in Various Concentrations for the Treatment of Probable Sleep Bruxism in Children and Adolescents: Controlled and Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214637
• Other study ID #: 69209423.4.0000.0268
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Adolescent
• Bruxism
• Children
• Sleep Bruxism
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

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