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

NCT06214637 | Unknown Phase 1 DMC

• 1 other identifier: 69209423.4.0000.0268
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Bruxism; Adolescent; Children; Temporomandibular Joint Disorders

Keywords

Sleep bruxism; Homeopathy; Adolescent; Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Melissa officinalis 6 CH

EXPERIMENTAL

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.

Drug: Melissa

Melissa officinalis 9 CH

EXPERIMENTAL

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.

Drug: Melissa

Melissa officinalis 12 CH

EXPERIMENTAL

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.

Drug: Melissa

Interventions

Melissa DRUG

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.

Melissa officinalis 12 CH; Melissa officinalis 6 CH; Melissa officinalis 9 CH

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 5 to 16 years;
• Patients with complete primary dentition, mixed or secondary dentition;
• Patients with probable sleep bruxism.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941-971, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Bruxism; Temporomandibular Joint Disorders

Interventions

lemon balm leaf extract

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Study Officials

• Lucianne Cople Maia, Phd

  Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

Central Study Contacts

Larissa Silva, Phd student

CONTACT

+55 21 3938-2101; lara_soares_14@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 19, 2024
• Study Start: August 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

BR (1)