Nocturnal Bruxism Clinical Trial
Official title:
Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism: a Controlled and Randomized Clinical Trial
This study aims to evaluate, through a crossover, controlled, double-blind and randomized clinical trial, the efficacy of Phytolacca decandra in association or not with Melissa officinalis in the treatment of children with nocturnal bruxism. Children from 3 to 12 years old with nocturnal bruxism will be randomly allocated into different groups of treatment stage as follows: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4) Phytolacca decandra associated with Melissa officinalis. All children will participate to each clinical stage, with a period of 14 days of whashout. Children and the principal investigator will be masked to treatment. The efficacy will be evaluated through parents report about the absence of tooth clenching or grinding by children and electromiography exams. The secondary outcomes that will be evaluated are: trait anxiety and quality of life related to oral health.
This is a randomized, double-blind, crossover, placebo-controlled study in which children
aged 3 to12 years old with nocturnal bruxism will be randomly allocated into different
phases of the study, according to treatment step: (1) placebo; (2) Phytolacca decandra; (3)
Melissa officinalis; (4) Phytolacca decandra associated with Melissa officinalis. This study
will be enrolled in Dental clinic of the Pediatric Dentistry department of Dental School, in
Federal University of Rio de Janeiro (UFRJ), from September 2014 to July 2017. All children
will participate of each clinical stages, with a washout interval of 14 days between the
phases. Children and the principal investigator will be masked to treatment.
After anamnesis, extra and intraoral clinical examination will be conducted at the beginning
of the study, by a single trained and calibrated examiner (the researcher responsible for
the study). Thus, facial symmetry, temporomandibular joints and masticatory muscle activity
should be observed. For the evaluation of the residual effect of bruxism in the muscles
(masseter and temporalis) of the masticatory system, electromyography exams will be
performed.
For intra-oral clinical examination, patients will be positioned comfortably in a dental
chair and the exam will be conducted with the aid of artificial light from dental reflector
mirror plane, exploratory probe and cotton tweezers. Data from each patient will also be
recorded in the dental records by a previously trained annotator. The presence of clinical
signs related to the presence of bruxism, such as the presence of dental enamel wear and
microfractures facets will also be evaluated.
The Brazilian version of ECOHIS (B-ECOHIS) will be used to assess the quality of life for
the selected children with 0-7 years old. This instrument will be applied before and after
each phase of the study. And, the Brazilian version of "Child Perceptions Questionnaire"
(CPQ) 8-10 and 11-14, will also be used to assess the physical and psychosocial impact of
nocturnal bruxism in children and adolescents in the study.
The child's anxiety will be observed by means of a rating scale of trait anxiety in
children. This scale will also be applied before and after each phase of the study.
All medicines, including placebo, will be placed in identical amber glass vials, which will
be labeled / encoded (A, B, C, D) and distributed ramdonly to children/parents, in
accordance with the phases of the study.
In every return, parents / guardians must give back the bottle used in the period to be
verified the residual volume. Thus, the intake of the medicine will be properly evaluated.
The subjects will be distributed within the treatment phases of the study in accordance with
the following medications:• Phase 1 - Placebo; • Phase 2 - Use isolated of Phytolacca
decandra 12CH; • Phase 3 - Use isolated of Melissa officinalis 12CH; • Phase 4 - Combined
use of Phytolacca decandra 12CH and Melissa officinalis 12CH.
Each drug, including placebo, will be formulated in Homeopathy Pharmacy, Faculty of
Pharmacy, UFRJ. They will be administered for a period of 30 days with a washout interval of
14 days between phases.
All test solutions will be packed in amber glass 30 ml with dropper and will be prepared at
the same time and under the same laboratory conditions. Supervision of all pharmaceutical
manipulation will be under the technical responsibility of at least one homeopathic
pharmaceutic.
Administration of the test medicines (solutions) will be made once a day, with the following
dosage: 01 drops of solution per age of the individual.
Patients and their caregivers must be informed that all products involving oral care
(toothpastes and mouthwashes) interfere with the absorption of homeopathic medicine, so the
15-minute interval should be preserved between the drug intake and self-care mouth of each
individual. It is emphasized that the use of the drug, quantity, time and frequency will be
informed through a written prescription.
The parents and/ or guardians will be responsible for helping monitoring the efficacy of the
treatments. At the first visit, they will receive a notebook that will serve as a sleep
diary. This instrument will be used for parents and / or guardians to describe their
self-perception of the sleep routine of their children.
In this appointment the parents and / or guardians will receive the researcher's
instructions about the completion of the daily diary. Thus, it will serve later as the
child's primary information before starting the use of medicines. This routine should be
maintained throughout the period of treatment, and in the resting phase (wash out), serving
as a home mirror, reflecting the effects presented by the child during the study period.
The frequency of nocturnal bruxism will be assessed using a Visual Analogue Scale. This
scale will be applied to parents and / or guardians in the first appointment to obtain the
frequency of bruxism of each child at the baseline. Also, it will be reapplied during all
phases for monitoring the clenching and grinding of the teeth.
A multiple logistic regression model will be applied to investigate the difference between
treatments.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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