Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658059
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|