Back to resultsA Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia
Primary Purpose
Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
verbal education
verbal education, visual aids, and motivational interviewing
Sponsored by
About this trial
This is an interventional prevention trial for Caries
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Traditional intervention: verbal education
New intervention: verbal education, visual aids, and motivational interviewing
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Follow up return rate
Number of participants who return for follow up in 1 - 2 weeks.
3-month recall return rate
Number of participants who return for follow up in 3 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT05212142
First Posted
January 25, 2022
Last Updated
August 11, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05212142
Brief Title
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia
Official Title
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional intervention: verbal education
Arm Type
Sham Comparator
Arm Title
New intervention: verbal education, visual aids, and motivational interviewing
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
verbal education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
verbal education, visual aids, and motivational interviewing
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in parental self-efficacy (PSE)
Description
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.
Time Frame
Baseline to 2 weeks
Title
Change in parent oral health knowledge
Description
A questionnaire developed by Alsada et al. will be adapted and used to test parent's knowledge of overall oral health.
Time Frame
Baseline to 2 weeks
Title
Follow up return rate
Description
Number of participants who return for follow up in 1 - 2 weeks.
Time Frame
2 weeks
Title
3-month recall return rate
Description
Number of participants who return for follow up in 3 months.
Time Frame
3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayakumar Jayaraman, DDS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia
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