Trial record 10 of 20 for:    Open Studies | "Dental Care"

Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

This study is currently recruiting participants.
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
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 April 17, 2014