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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212142
• Other study ID #: HM20023677
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: August 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 15, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Recurrence
• Stomatognathic Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Follow up return rate	Number of participants who return for follow up in 1 - 2 weeks.	2 weeks
Primary	3-month recall return rate	Number of participants who return for follow up in 3 months.	3 months