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

PHASE1RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

August 30, 2024

Study Completion Date

September 30, 2024

Conditions
Sleep BruxismAdolescentChildrenTemporomandibular Joint Disorders
Interventions
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.

DRUG

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.

Trial Locations (1)

21941-971

RECRUITING

Universidade Federal do Rio de Janeiro, Rio de Janeiro

All Listed Sponsors
lead

Universidade Federal do Rio de Janeiro

OTHER