Overview

This trial is active, not recruiting.

Condition children's dental anxiety
Treatments homeopathic remedy, placebo
Sponsor Hadassah Medical Organization
Start date September 2012
End date December 2014
Trial size 30 participants
Trial identifier NCT01658059, rcauhr-HMO-CTIL

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Arm
(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.

Primary Outcomes

Measure
Reducing Children's Anxiety
time frame: Each dental apointment, aproximatly 30 minutes on the average

Eligibility Criteria

Male or female participants from 5 years up to 12 years old.

Inclusion Criteria: - Dental anxiety - Needs at least 2 dental treatment appointments Exclusion Criteria: - Medically compromised - Cooperative, needs less than 2 dental treatment appointments

Additional Information

Official title Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.