A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments.

Official Title
-----------------
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia: a Randomized Controlled Trial

Conditions
-----------------
Caries

Intervention / Treatment
-----------------
* Behavioral: verbal education
* Behavioral: verbal education, visual aids, and motivational interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parent with child (patient) planned for dental treatment with general anesthesia (GA) parent of a child (patient) age less than six parent of a child (patient) with health status of healthy (American Society of Anesthesiologists (ASA) I or II). Exclusion Criteria: parents/guardians who chose not to participate in the study parents who spoke a language other than English or Spanish Parents of a child (patient) with special health care needs or patients of ASA III or IV status

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Traditional intervention: verbal education<br> | Behavioral: verbal education<br>* Participants will receive oral health anticipatory guidance in the form of verbal and written education alongside the same preventive follow up and recall appointment schedule.<br>|
| Experimental: New intervention: verbal education, visual aids, and motivational interviewing<br> | Behavioral: verbal education, visual aids, and motivational interviewing<br>* Participants will receive oral health anticipatory guidance through a combination preventive strategy using motivational interviewing, individualized goal setting, visual aids, and verbal education alongside a preventive follow up and recall appointment schedule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parental self-efficacy (PSE) | The PSE questionnaire adapted from an combination of questions developed by Dumka et al. and Johnston & Mash will measure parents perceived self-efficacy in controlling their child's oral health. | Baseline to 2 weeks | 
| Change in parent oral health knowledge | A questionnaire developed by Alsada et al. will be adapted and used to test parent's knowledge of overall oral health. | Baseline to 2 weeks | 
| Follow up return rate | Number of participants who return for follow up in 1 - 2 weeks. | 2 weeks | 
| 3-month recall return rate | Number of participants who return for follow up in 3 months. | 3 months |