Sleep BruxismPhase 1NCT06214637
Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents
A Phase 1 study testing Melissa in people with Sleep Bruxism and Adolescent, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Adolescent, Children
- What is being tested?
- Melissa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 5 to 16 years;
- Patients with complete primary dentition, mixed or secondary dentition;
- Patients with probable sleep bruxism.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, 21941-971
Larissa Silva, Phd student, +55 21 3938-2101, lara_soares_14@hotmail.com
About this study
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
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
- Being tested
- Melissa, Placebo
- Keywords
- Sleep bruxism, Homeopathy, Adolescent, Children
- Medical subject headings
- Sleep Bruxism, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelissaDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Melissa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Aug 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larissa Soares Lima da Silva, Universidade Federal do Rio de Janeiro
- Investigators
- Lucianne Cople Maia, Phd, Study director, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214637
- Sponsor's protocol ID
- 69209423.4.0000.0268
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results will be released after the completion of the clinical trial, which forms part of the responsible researcher's Phd thesis.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06214637
- Acronym / sponsor ID
- 69209423.4.0000.0268
- Conditions
- Sleep Bruxism, Adolescent, Children, Temporomandibular Joint Disorders
- Keywords
- Sleep bruxism, Homeopathy, Adolescent, Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIt 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. |
| Melissa officinalis 6 CH | Experimental | Drug: MelissaIt 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. |
| Melissa officinalis 9 CH | Experimental | Drug: MelissaIt 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. |
| Melissa officinalis 12 CH | Experimental | Drug: MelissaIt 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 5 to 16 years;
- Patients with complete primary dentition, mixed or secondary dentition;
- Patients with probable sleep bruxism.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelissaThe 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 | Melissa officinalis 12 CH, Melissa officinalis 6 CH, Melissa officinalis 9 CH |
| PlaceboIt 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 |
Primary outcome
General objective
Time frame: Twice a month
Number of participants who had a positive response to the proposed treatment, that is a reduction in bruxism episodes during the sleep period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Undecided. The results will be released after the completion of the clinical trial, which forms part of the responsible researcher's Phd thesis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucianne Cople Maia, Phd study director
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melissa in people with Sleep Bruxism and Adolescent, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Larissa Silva, Phd student (+55 21 3938-2101 ext. UFRJ, lara_soares_14@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General objective (time frame: Twice a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.