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

NCT05212142 | Completed

• 1 other identifier: HM20023677
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Traditional intervention: verbal education

SHAM COMPARATOR

Behavioral: verbal education

New intervention: verbal education, visual aids, and motivational interviewing

EXPERIMENTAL

Behavioral: verbal education, visual aids, and motivational interviewing

Interventions

verbal education BEHAVIORAL

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.

Traditional intervention: verbal education

verbal education, visual aids, and motivational interviewing BEHAVIORAL

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

New intervention: verbal education, visual aids, and motivational interviewing

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Audiovisual Aids; Motivational Interviewing

Intervention Hierarchy (Ancestors)

Educational Technology; Technology; Technology, Industry, and Agriculture; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jayakumar Jayaraman, DDS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: January 27, 2022
• Study Start: June 10, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)