Clinical trial NCT06214637: Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Sleep Bruxism
Adolescent
Children
Temporomandibular Joint Disorders
Keywords: Sleep bruxism
Homeopathy
Adolescent
Children
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: General objective
timeFrame: Twice a month
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Lucianne Cople Maia, Phd
role: STUDY_DIRECTOR
References: