NCT03909243

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

April 5, 2019

Last Update Submit

April 8, 2019

Conditions

Keywords

psychological attributeschild mental disordersstrength and difficulties questionnairechild behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Actual child behavior during the dental treatment.

    6 months

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Out patients of Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry, Cairo University, Egypt who are having a dental problem and coming for their first dental visit.

You may qualify if:

  • Children: school aged children (4 to 7) years old
  • Teeth: carious teeth requiring a simple dental treatment (cavity preparation with restoration)

You may not qualify if:

  • Children:
  • Medically compromised children.
  • Children with previous dental history.
  • Refusal of participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental DisordersNeurodevelopmental DisordersChild Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sandra M Anwar, BSc

    Resident at pediatric Dentistry and Dental Public Health Department

    PRINCIPAL INVESTIGATOR
  • Sara A Mahmoud, phD

    Associate professor at pediatric Dentistry and Dental Public Health Department

    STUDY DIRECTOR

Central Study Contacts

Sara A Mahmoud, phD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 9, 2019

Study Start

August 1, 2019

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

April 9, 2019

Record last verified: 2019-04