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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05212142
Collaborator
(none)
150
1
2
9.7
15.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: verbal education
  • Behavioral: verbal education, visual aids, and motivational interviewing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia: a Randomized Controlled Trial
Actual Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in parental self-efficacy (PSE) [Baseline to 2 weeks]

    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.

  2. Change in parent oral health knowledge [Baseline to 2 weeks]

    A questionnaire developed by Alsada et al. will be adapted and used to test parent's knowledge of overall oral health.

  3. Follow up return rate [2 weeks]

    Number of participants who return for follow up in 1 - 2 weeks.

  4. 3-month recall return rate [3 months]

    Number of participants who return for follow up in 3 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05212142
Other Study ID Numbers:
  • HM20023677
First Posted:
Jan 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022