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

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

The purpose of this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments.

Study Overview

• Status: Completed
• Conditions: Caries
• Intervention / Treatment: Behavioral: verbal education; Behavioral: verbal education, visual aids, and motivational interviewing

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. parent with child (patient) planned for dental treatment with general anesthesia (GA)
2. parent of a child (patient) age less than six
3. parent of a child (patient) with health status of healthy (American Society of Anesthesiologists (ASA) I or II).

Exclusion Criteria:

1. parents/guardians who chose not to participate in the study
2. parents who spoke a language other than English or Spanish
3. Parents of a child (patient) with special health care needs or patients of ASA III or IV status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Traditional intervention: verbal education	Behavioral: verbal education; 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.
Experimental: New intervention: verbal education, visual aids, and motivational interviewing	Behavioral: verbal education, visual aids, and motivational interviewing; 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

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jayakumar Jayaraman, DDS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Stomatognathic Diseases
• Other Study ID Numbers: HM20023677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No