Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01658059

Enrollment

Registered

2012-08-06

Start date

2012-09-30

Completion date

2015-12-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children's Dental Anxiety

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.

Interventions

OTHERHomeopathic remedy

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

* Dental anxiety * Needs at least 2 dental treatment appointments

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Reducing Children's Anxiety	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 .

Countries

Israel

Participant flow

Participants by arm

Arm	Count
All Study Population cross over design. Group 1 got homeopathic remedy on the first dental treatment, and placebo on the second treatment. Group 2 got placebo on the first dental treatment, homeopathic remedy on the second treatment	11
Total	11

Baseline characteristics

Characteristic	All Study Population	—
Age, Continuous	7.09 years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Israel	11 participants	—
Sex: Female, Male Female	7 Participants	—
Sex: Female, Male Male	4 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 11
other Total, other adverse events	0 / 11	0 / 11
serious Total, serious adverse events	0 / 11	0 / 11

Outcome results

Primary