Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Children's Dental Anxiety Clinical Trial

Official title:

Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658059
• Other study ID #: rcauhr-HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2019
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Dental anxiety

• Needs at least 2 dental treatment appointments

Exclusion Criteria:

• Medically compromised

• Cooperative, needs less than 2 dental treatment appointments

Related Conditions & MeSH terms

• Anxiety Disorders
• Children's Dental Anxiety

Intervention

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
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing Children's Anxiety	Measuring levels of salivary cortisol and salivary a-amylase levels before dental treatment and after dental treatment .	Each dental apointment, aproximatly 30 minutes on the average