Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
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|ClinicalTrials.gov Identifier: NCT01658059|
Recruitment Status : Unknown
Verified March 2015 by Moti Moskovitz, Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : March 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Children's Dental Anxiety||Other: Homeopathic remedy Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
Other: Homeopathic remedy
drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.
|Placebo Comparator: Placebo||
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 [ Time Frame: Each dental apointment, aproximatly 30 minutes on the average ]The homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment. Studies demonstrated elevation of salivary cortisol and salivary α-amylase levels before the dental treatment, and lower levels after the dental treatment in children and adults. The average level of salivary α-amylase activity in healthy children was about 41.1% lower after dental treatment (39.27U/ml), compared to levels found before treatment (66.65 U/ml).Cortisol level after dental treatment was 0.66 mg/dl, compared to 0.74 mg/dl that was measured before treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658059
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|