NCT04815759

Brief Summary

Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 20, 2021

Last Update Submit

March 24, 2021

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

  • Dental anxiety level

    Assessment will performed by using Facial image scale (FIS)It consists of 5 faces ranging from very happy to very unhappy. At the beginning, the 5 faces have been explained to all children and they were asked to point to the face which best describes how he/she felt at the moment

    through study completion, an average of 3 months

Study Arms (2)

Pre pandemic

Other: routine dental restorative procedures

Post pandemic

Other: routine dental restorative procedures

Interventions

routine dental restorative proceduresOTHER

pulp and restorative therapy

Post pandemicPre pandemic

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with an age range 4-6 years attending the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University

You may qualify if:

  • parental consent
  • no previous dental experience
  • medically free children

You may not qualify if:

  • children with negative behavior according to Frankl Rating Scale
  • children require general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

RECRUITING

Central Study Contacts

Dalia M Talaat, phd

CONTACT

01221037275dalia.talaat@dent.alex.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 25, 2021

Study Start

March 1, 2021

Primary Completion

April 27, 2021

Study Completion

April 30, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations

EG(1)