Children's Dental AnxietyNCT01658059
Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
A study testing Homeopathic remedy in people with Children's Dental Anxiety, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children's Dental Anxiety
- What is being tested?
- Homeopathic remedy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Dental anxiety
- Needs at least 2 dental treatment appointments
Who cannot join
- Medically compromised
- Cooperative, needs less than 2 dental treatment appointments
Trial locations and contacts
1 site in 1 country.
About this study
Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment.
Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment.
Read more
- To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children.
Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale.
Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.
- Conditions
- Children's Dental Anxiety
- Being tested
- Homeopathic remedy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathic remedyOther
drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.
PlaceboOther
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | homeopathic remedy first , placebo second Receives: Other: Homeopathic remedy; Other: Placebo |
| group 2 | Experimental | placebo first, homeopathic remedy second Receives: Other: Homeopathic remedy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing Children's Anxiety
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
Measured: Each dental apointment, aproximatly 30 minutes on the average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Children's Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moti Moskovitz, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658059
- Sponsor's protocol ID
- rcauhr-HMO-CTIL
- Status last verified
- Mar 2019
- First submitted
- 21 Jul 2012
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
- ClinicalTrials.gov ID
- NCT01658059
- Acronym / sponsor ID
- rcauhr-HMO-CTIL
- Conditions
- Children's Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment.
Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment.
- To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children.
Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale.
Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: Homeopathic remedy, Other: Placebohomeopathic remedy first , placebo second |
| group 2 | Experimental | Other: Homeopathic remedy, Other: Placeboplacebo first, homeopathic remedy second |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Dental anxiety
- Needs at least 2 dental treatment appointments
Key exclusion criteria (2 listed)
- Medically compromised
- Cooperative, needs less than 2 dental treatment appointments
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 |
|---|---|---|
| Homeopathic remedydrops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day. | Other | group 1, group 2 |
| Placebodrops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day. | Other | group 1, group 2 |
Primary outcome
Reducing Children's Anxiety
Time frame: Each dental apointment, aproximatly 30 minutes on the average
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeopathic remedy in people with Children's Dental Anxiety, run by Hadassah Medical Organization at 1 site in Israel.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 20 Mar 2019. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing Children's Anxiety (time frame: Each dental apointment, aproximatly 30 minutes on the average). 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 20 Mar 2019.