Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - A dyad of children who are 3-17 years of age and their primary caregiver - Children who need at least two restorative appointments - Primary caregivers who are fluent in English Exclusion Criteria: - Children who have a visual impairment - Children who need protective stabilization to immobilize children's body for treatment - Children who are not able to hold the mirror - Children who don't have ability to answer the questions


NCT ID:

NCT02366520


Primary Contact:

Principal Investigator
Masahiro Heima, DDS, PhD
Case Western Reserve University

Masahiro Heima, DDS, PhD
Phone: 216 368 1379
Email: masahiro.heima@case.edu


Backup Contact:

Email: axg773@case.edu
Antonette Green
Phone: 216 368 3277


Location Contact:

Cleveland, Ohio 44106
United States

Masahiro Heima, DDS, PhD
Phone: 216-368-1379
Email: masahiro.heima@case.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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