An interventional study of Homeopathic remedy and Placebo in Children's Dental Anxiety, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Other
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
homeopathic remedy first , placebo second
Other: Homeopathic remedy · Other: Placebo
placebo first, homeopathic remedy second
Other: Homeopathic remedy · Other: Placebo
drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.
Reducing Children's Anxiety
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
Time frame: Each dental apointment, aproximatly 30 minutes on the average
| Milestone | Homeopathic Remedy First, Then Placebo | Placebo First, Then Homeopathic Remedy |
|---|---|---|
| Started | 12 | 10 |
| Completed | 6 | 5 |
| Not completed | 6 | 5 |
| Milestone | Homeopathic Remedy First, Then Placebo | Placebo First, Then Homeopathic Remedy |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Homeopathic Remedy First, Then Placebo | Placebo First, Then Homeopathic Remedy |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
| ng/ml | Homeopathic Remedy | Placebo |
|---|---|---|
| cortisol pre treatment | 1.38 ± 1.45 | 2.28 ± 3.09 |
| cortisol post treatment | 1.39 ± 2.9 | 4.37 ± 6.91 |
| alpha amylase pre treatment | 56.02 ± 45.72 | 92.09 ± 110.65 |
| alpha amylase post treatment | 76.82 ± 54.48 | 102.62 ± 104.42 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Homeopathic Remedy | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | All Study Population |
|---|---|
| Mean | 7.09 (5 to 9) |
| Sex: Female, Male(Participants) | All Study Population |
|---|---|
| Female | 7 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | All Study Population |
|---|
| Region of Enrollment(participants) | All Study Population |
|---|---|
| Israel | 11 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization