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Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism

Primary Purpose

Nocturnal Bruxism

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Phytolacca decandra
Melissa officinalis
Phyt.decandra + Melissa offic.
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Bruxism focused on measuring Bruxism, Sleep bruxism, Sleep related bruxism, Homeopathy

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Children with good general health; children aged 03-12 years old; children with nocturnal bruxism reported by their parents/guardians.

Exclusion criteria:

  • Children with special needs (frame psychological, psychiatric and neurological disorders or any systemic commitments)
  • Children with carious lesions in dentin
  • Children with orthodontic appliances
  • Children with dental anomalies
  • Children with dental erosions
  • Children with the following malocclusions: Class II and III of Angle, crossbite and open bite
  • Children that will be in any medication that modify the salivary flow and / or cause alteration of the central nervous system.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Placebo

    Phytolacca decandra

    Melissa officinalis

    Phyt.decandra + Melissa offic.

    Arm Description

    Placebo

    The Phytolacca decandra with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.

    The Melissa officinalis with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.

    The combination of Phytolacca decandra with Melissa offcicinalis with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.

    Outcomes

    Primary Outcome Measures

    Evaluation of efficacy of Phytolacca decandra in association or not with Melissa officinalis in comparison of placebo in arresting nocturnal bruxism, by the use of a visual analog scale
    Parents / guardians will be asked to schedule a graduated visual analog scale from 0 to 10 to determine bruxism level (absence or not of tooth clenching or grinding) of your child during the 30 days of each medicine usage and also during the washout period.
    Evaluation of the efficacy of Phytolacca decandra in association or not with Melissa officinalis in comparison of placebo in arresting nocturnal bruxism, by the electromiography analysis
    All children will be submitted to eletromiography analysys to measure the masseter and temporalis muscles forces before and after each tretament stage.

    Secondary Outcome Measures

    Identify changes in the quality of life children with bruxism before and after treatments by the use of B-ECOHIS and PCP-Q questionaries
    Parents / guardians will answer questionnaires to determine their children' quality of life related to oral health before and after each stage of the study.

    Full Information

    First Posted
    July 28, 2016
    Last Updated
    August 12, 2016
    Sponsor
    Universidade Federal do Rio de Janeiro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02870543
    Brief Title
    Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism
    Official Title
    Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism: a Controlled and Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio de Janeiro

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nocturnal Bruxism
    Keywords
    Bruxism, Sleep bruxism, Sleep related bruxism, Homeopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    Phytolacca decandra
    Arm Type
    Active Comparator
    Arm Description
    The Phytolacca decandra with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.
    Arm Title
    Melissa officinalis
    Arm Type
    Active Comparator
    Arm Description
    The Melissa officinalis with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.
    Arm Title
    Phyt.decandra + Melissa offic.
    Arm Type
    Experimental
    Arm Description
    The combination of Phytolacca decandra with Melissa offcicinalis with 12CH dosage will be administered (one drop per age of the child) once a day during 30 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Phytolacca decandra
    Other Intervention Name(s)
    homeopathic medicine
    Intervention Description
    Treatment of bruxism
    Intervention Type
    Drug
    Intervention Name(s)
    Melissa officinalis
    Other Intervention Name(s)
    homeopathic medicine
    Intervention Description
    Treatment of bruxism
    Intervention Type
    Drug
    Intervention Name(s)
    Phyt.decandra + Melissa offic.
    Other Intervention Name(s)
    homeopathic medicine complex
    Intervention Description
    Treatment of bruxism
    Primary Outcome Measure Information:
    Title
    Evaluation of efficacy of Phytolacca decandra in association or not with Melissa officinalis in comparison of placebo in arresting nocturnal bruxism, by the use of a visual analog scale
    Description
    Parents / guardians will be asked to schedule a graduated visual analog scale from 0 to 10 to determine bruxism level (absence or not of tooth clenching or grinding) of your child during the 30 days of each medicine usage and also during the washout period.
    Time Frame
    During the period of treatments and washout : 168 days
    Title
    Evaluation of the efficacy of Phytolacca decandra in association or not with Melissa officinalis in comparison of placebo in arresting nocturnal bruxism, by the electromiography analysis
    Description
    All children will be submitted to eletromiography analysys to measure the masseter and temporalis muscles forces before and after each tretament stage.
    Time Frame
    Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days
    Secondary Outcome Measure Information:
    Title
    Identify changes in the quality of life children with bruxism before and after treatments by the use of B-ECOHIS and PCP-Q questionaries
    Description
    Parents / guardians will answer questionnaires to determine their children' quality of life related to oral health before and after each stage of the study.
    Time Frame
    Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days
    Other Pre-specified Outcome Measures:
    Title
    Identify changes in the trait anxiety of children with bruxism before and after treatments by the use of the Brazilian validated version of the Trait-anxiety Scale
    Description
    Parents/guardians will answer the questionnaire (the Brazilian validated version of the Trait-anxiety Scale) to determine their children trait anxiety.
    Time Frame
    Before to start all treatments (baseline) and after each treatment (every 30 days) up to 168 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Children with good general health; children aged 03-12 years old; children with nocturnal bruxism reported by their parents/guardians. Exclusion criteria: Children with special needs (frame psychological, psychiatric and neurological disorders or any systemic commitments) Children with carious lesions in dentin Children with orthodontic appliances Children with dental anomalies Children with dental erosions Children with the following malocclusions: Class II and III of Angle, crossbite and open bite Children that will be in any medication that modify the salivary flow and / or cause alteration of the central nervous system.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrea G. Antonio, Adjunct Professor
    Organizational Affiliation
    Universidade Federal do Rio de Janeiro
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Lucianne Cople Maia, Full Professor
    Organizational Affiliation
    Universidade Federal do Rio de Janeiro
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Cláudia Tavares, Ph.D student
    Organizational Affiliation
    Universidade Federal do Rio de Janeiro
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism

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