Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Not Applicable

Completed

• Conditions: Children's Dental Anxiety
• Interventions: Other: Homeopathic remedy; Other: Placebo

• Registration Number: NCT01658059
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-21
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Results First Submitted: 2017-08-21
• Results First Submitted QC: 2018-11-19
• Status Verified: 2019-03
• Results First Posted: 2019-03-11
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Dental anxiety
• Needs at least 2 dental treatment appointments

Exclusion Criteria

• Medically compromised
• Cooperative, needs less than 2 dental treatment appointments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group 1	Placebo	homeopathic remedy first , placebo second
group 1	Homeopathic remedy	homeopathic remedy first , placebo second
group 2	Homeopathic remedy	placebo first, homeopathic remedy second
group 2	Placebo	placebo first, homeopathic remedy second

Primary Outcome Measures

Name	Time	Method
Reducing Children's Anxiety	Each dental apointment, aproximatly 30 minutes on the average	Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel