Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

March 11, 2019 updated by: Moti Moskovitz, Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dental anxiety
  • Needs at least 2 dental treatment appointments

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
homeopathic remedy first , placebo second
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.
Other: Placebo
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.
Experimental: group 2
placebo first, homeopathic remedy second
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.
Other: Placebo
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing Children's Anxiety
Time Frame: 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 .
Each dental apointment, aproximatly 30 minutes on the average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 21, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rcauhr-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Children's Dental Anxiety

Clinical Trials on Homeopathic remedy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe