- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909243
Assessment of Child Psychological Attributes for Prediction of Child Behavior at First Dental Visit
Assessment of Child Psychological Attributes Using Strength and Difficulties Questionnaire for Prediction of Child Behavior at First Dental Visit Through: A Cross Sectional Study
One of the most prevalent chronic diseases worldwide is mental disorder, including social, emotional, and behavioral problems, and it is the fifth main cause of global disability . In Egypt, it is estimated that 20.6% of children aged from 6-12 years had behavioral problems
Behavioral and emotional problems may affect deeply child's quality of life, such as impairment of school life (high absence), They may cause nutritional imbalance and even suicidal thoughts. Therefore, both the dentist and the family should be adequately prepared to deal with those children who come seeking dental treatment.
Recently, studies proved the association between the psychological characteristics and the behavior of children in dental setting. There was a study that showed that there is a relation between psychological functioning of the child, dental anxiety and his/her behaviour during dental appointment. Furthermore, it was found that there is a correlation between the temperamental difficulties or emotional problems of the child and the non-cooperative behavior during the process of injection of the local anesethia.
These studies ensures the importance of understanding the effect of mental disorders on the behavior of children during dental treatment, as it would help the professionals to properly plan the clinic appointments without any delay or cancellation of the appointment and allows him to render effective and efficient dental treatment.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children: school aged children (4 to 7) years old
- Teeth: carious teeth requiring a simple dental treatment (cavity preparation with restoration)
Exclusion Criteria:
Children:
- Medically compromised children.
- Children with previous dental history.
- Refusal of participation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child psychological attributes
Time Frame: 6 months
|
Total difficulty score using strengths and difficulties questionnaire (0-40) 0-13 normal 14-16 border line 17-40 abnormal |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Actual child behavior during the dental treatment.
Time Frame: 6 months
|
Rating (0-4) using Fankl scale Rating 1 (--) definitely negative Refusal of treatment, forceful crying, fearfulness or any other overt evidence of extreme negativism. Rating 2 (-) negative Reluctance to accept treatment, uncooperativeness, some evidence of negative attitude but not pronounced. Rating 3 (+) positive Acceptance of treatment, cautious behaviour at times willingness to comly with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively. Rating 4 (++) definitely positive Good rapport with the dentist, interest in the dental procedure, laughing and enjoying the situation. |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandra M Anwar, BSc, Resident at pediatric Dentistry and Dental Public Health Department
- Study Director: Sara A Mahmoud, phD, Associate Professor at Pediatric Dentistry and Dental Public Health Department
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14422017495365
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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