Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT02366520
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2015-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Handheld Mirror to Improve Child's Behavior During Dental Treatment
Sponsor:
Case Western Reserve University
Organization:
Study Overview
Official Title:
Using a Handheld Mirror to Improve Child's Behavior During Dental Treatment
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a handheld mirror helps to reduce child behavior problems during dental treatment. It will be tested by randomized crossover design. Child participants will receive dental treatment under two conditions: during one of the treatment days the child will be given a handheld mirror; another treatment will be done without the child having the mirror. Each condition will be assign on separate days, and the day, which the child has the mirror, will be assigned by chance.
Detailed Description:
Participants, including 3-17 years old children and primary caregivers as well as pediatric dentists and dental assistants, will be recruited at the Irving and Jeanne Tapper Pediatric Dental Center at University Hospitals Rainbow Babies \& Children's Hospital in Cleveland, Ohio. Instructional sessions will provide proper use of a handheld mirror to pediatric dentists and dental assistants.
On the first dental appointment:
After obtain consent and assent form, the caregiver will be asked to complete a questionnaire, "Questionnaire for Caregiver", which includes questions to assess the caregiver's dental anxiety level, the caregiver's perception of the child's dental fear level, and collect characteristic information such as age and gender. The child will also be asked to complete a questionnaire; a 3-6 years old child will complete the questionnaire "Questionnaire for Child 3-6," which includes the face image scale to measure his/her level of dental anxiety; a 7-17 years old child will complete the questionnaire "Questionnaire for Child 7-17," which includes the face image scale and the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS) to measure his/her level of dental anxiety.
The child will then be randomly assigned to either Group 1, in which the child will receive the dental treatment with the mirror at the first visit and receive dental treatment without the mirror at the second visit, or Group 2, which will receive dental treatment without the mirror on the first visit and receive dental treatment with the mirror on the second visit. The child's, dentists' and dental assistants' behavior will be video recorded during treatment. The dentist will guide the child to see the inside of his or her mouth during the dental care procedure. At the end of appointment, children who are 7 -17 years old will be asked the ease of receiving dental treatment by a 5 point Likert scale.
On the second appointment, the same procedure will occur including the questionnaire and video recording.
However, the child who has been assigned to Group 1 will not have a mirror and the child who has been assigned to Group 2 will have a mirror during dental procedures.
The questionnaire and video files will be stored in a secure location which protected passwords.
Behavioral data will be coded, counted and assessed.
The child's chart will be reviewed to find the child's temperament and to count the total number of primary teeth, permanent teeth, decayed, filled, and extracted teeth due to dental caries at the examination visit.
Data analyses:
The impact of the mirror will be measured by the following variables and analyzed using the children's behavior after controlling for the children's characteristic and procedures:
1. Subject characteristic analysis
2. Comparison of variables of behavior between study group and control group after controlling for the subject's characteristics and dental treatment procedures
On the first dental appointment:
After obtain consent and assent form, the caregiver will be asked to complete a questionnaire, "Questionnaire for Caregiver", which includes questions to assess the caregiver's dental anxiety level, the caregiver's perception of the child's dental fear level, and collect characteristic information such as age and gender. The child will also be asked to complete a questionnaire; a 3-6 years old child will complete the questionnaire "Questionnaire for Child 3-6," which includes the face image scale to measure his/her level of dental anxiety; a 7-17 years old child will complete the questionnaire "Questionnaire for Child 7-17," which includes the face image scale and the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS) to measure his/her level of dental anxiety.
The child will then be randomly assigned to either Group 1, in which the child will receive the dental treatment with the mirror at the first visit and receive dental treatment without the mirror at the second visit, or Group 2, which will receive dental treatment without the mirror on the first visit and receive dental treatment with the mirror on the second visit. The child's, dentists' and dental assistants' behavior will be video recorded during treatment. The dentist will guide the child to see the inside of his or her mouth during the dental care procedure. At the end of appointment, children who are 7 -17 years old will be asked the ease of receiving dental treatment by a 5 point Likert scale.
On the second appointment, the same procedure will occur including the questionnaire and video recording.
However, the child who has been assigned to Group 1 will not have a mirror and the child who has been assigned to Group 2 will have a mirror during dental procedures.
The questionnaire and video files will be stored in a secure location which protected passwords.
Behavioral data will be coded, counted and assessed.
The child's chart will be reviewed to find the child's temperament and to count the total number of primary teeth, permanent teeth, decayed, filled, and extracted teeth due to dental caries at the examination visit.
Data analyses:
The impact of the mirror will be measured by the following variables and analyzed using the children's behavior after controlling for the children's characteristic and procedures:
1. Subject characteristic analysis
2. Comparison of variables of behavior between study group and control group after controlling for the subject's characteristics and dental treatment procedures
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: