Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Moti Moskovitz, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01658059
First received: July 21, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Children's Dental Anxiety
Other: Homeopathic remedy
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Reducing Children's Anxiety [ Time Frame: Each dental apointment, aproximatly 30 minutes on the average ] [ Designated as safety issue: No ]
    The homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment. Studies demonstrated elevation of salivary cortisol and salivary α-amylase levels before the dental treatment, and lower levels after the dental treatment in children and adults. The average level of salivary α-amylase activity in healthy children was about 41.1% lower after dental treatment (39.27U/ml), compared to levels found before treatment (66.65 U/ml).Cortisol level after dental treatment was 0.66 mg/dl, compared to 0.74 mg/dl that was measured before treatment.


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Anxiety reduction 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 Other: Placebo
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Dental anxiety
  • Needs at least 2 dental treatment appointments

Exclusion Criteria:

  • Medically compromised
  • Cooperative, needs less than 2 dental treatment appointments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658059

Contacts
Contact: Moti Moskovitz, DMD, PhD 972-2-6776122 motim@md.huji.ac.il
Contact: Hadas Lemberg, PhD : 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Moti Moskovitz, clinical senior lecturer, department of pediatric dentistry, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01658059     History of Changes
Other Study ID Numbers: rcauhr-HMO-CTIL
Study First Received: July 21, 2012
Last Updated: June 12, 2013
Health Authority: Israel: Ministry of Health - Director General

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014