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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.
2. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | homeopathic remedy first , placebo second |
|
| group 2 | Experimental | placebo first, homeopathic remedy second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Homeopathic remedy | Other | drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reducing Children's Anxiety | Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment . | Each dental apointment, aproximatly 30 minutes on the average |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Homeopathic Remedy First, Then Placebo | Homeopathic Remedy first, washout period and then Placebo |
| FG001 | Placebo First, Then Homeopathic Remedy | Placebo first, washout period and then Homeopathic Remedy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention- 2 Days |
| |||||||||||||
| Washout Period- 14 Days |
| |||||||||||||
| Second Intervention- 2 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Population | cross over design. Group 1 got homeopathic remedy on the first dental treatment, and placebo on the second treatment. Group 2 got placebo on the first dental treatment, homeopathic remedy on the second treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reducing Children's Anxiety | Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment . | Posted | Mean | Standard Deviation | ng/ml | Each dental apointment, aproximatly 30 minutes on the average |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Homeopathic Remedy | Cross over design. Group 1 got homeopathic remedy on the first dental treatment. Group 2 got homeopathic remedy on the second treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moti Moskovitz | Hadassah Medical Organization | motim@ekmd.huji.ac.il |
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| ID | Term |
|---|---|
| D006705 | Homeopathy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Placebo | Other | drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Cross over design. Group 1 got placebo on the second dental treatment. Group 2 got placebo on the first treatment. | 0 | 11 | 0 | 11 | 0 | 11 |
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