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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03909243
Other study ID # 14422017495365
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2019
Est. completion date July 2020

Study information

Verified date April 2019
Source Cairo University
Contact Sandra M Anwar, BSc
Phone 01224774226
Email Sandra_jacob@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

this study aims to acknowledge the different psychological attributes among children seeking dental treatment at young age and to assess the association between child psychological attributes and his/her behavior in dental clinic.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date July 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Child psychological attributes Total difficulty score using strengths and difficulties questionnaire (0-40)
0-13 normal
14-16 border line
17-40 abnormal
6 months
Secondary Actual child behavior during the dental treatment. 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
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