Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

NCT ID: NCT01658059

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Children's Dental Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

group 1

homeopathic remedy first , placebo second

Group Type: EXPERIMENTAL

Homeopathic remedy

Intervention Type: OTHER

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

Placebo

Intervention Type: OTHER

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

group 2

placebo first, homeopathic remedy second

Group Type: EXPERIMENTAL

Homeopathic remedy

Intervention Type: OTHER

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

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Dental anxiety
• Needs at least 2 dental treatment appointments

Exclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Moti Moskovitz

clinical senior lecturer, department of pediatric dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

rcauhr-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id