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Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

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ClinicalTrials.gov Identifier: NCT01658059
Recruitment Status : Unknown
Verified March 2015 by Moti Moskovitz, Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Moti Moskovitz, 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.


Condition or disease Intervention/treatment Phase
Children's Dental Anxiety Other: Homeopathic remedy Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Reducing Children's Anxiety [ Time Frame: Each dental apointment, aproximatly 30 minutes on the average ]
    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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658059


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization

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
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders