NCT06928493

Brief Summary

Changes in the dental office environment during the pandemic may affect the children's dental anxiety. This double-blind, randomized, controlled clinical study aimed to assess children's dental anxiety focusing on changes in the dental office environment with the Child Drawing: Hospital (CD: H) picture test.The results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. The evaluations from the psychiatrist and dentist using CD: H were highly consistent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 14, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

anxiety,child

Outcome Measures

Primary Outcomes (1)

  • Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test

    It is aimed to assess children's dental anxiety focusing on changes in the dental office environment with the Child Drawing: Hospital (CD: H) picture test.

    3 months

Study Arms (2)

Pandemic Clinical Conditions (PCC)

The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor.

Other: oral examination

Conventional Clinical Conditions (CCC)

The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.

Other: oral examination

Interventions

The pre-examination behaviors and attitudes of the children included in the study were measured by an independent dentist (Ş.Y.İ) using the Frankl Behavior Rating Scale (FS). Following this, the children were randomly divided into two groups PCC and CCC . The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor. The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.After that, patients were asked to draw themselves or the pediatric dentist who performed the examination. A child psychiatrist (B.A.S.) and a pediatric dentist (R.D) with an internationally valid "Child Drawing Analysis" training certificate evaluated the children's drawings independently.

Conventional Clinical Conditions (CCC)Pandemic Clinical Conditions (PCC)

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

120 healthy patient aged 5-7 years who had no prior dentistry experience and whose parents agree to participate in the study,children willing to draw were included the study

You may qualify if:

  • Healthy children children between 5-7 years old no prior dentistry experience children willing to draw picture

You may not qualify if:

  • Children who had mental or physical disabilities children \< 5 years old, previous dentist experience who refused to draw picture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Çankaya, Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Sharma A, Jain MB. Pediatric Dentistry during Coronavirus Disease-2019 Pandemic: A Paradigm Shift in Treatment Options. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):412-415. doi: 10.5005/jp-journals-10005-1809.

  • Assathiany R, Salinier C, Bechet S, Dolard C, Kochert F, Bocquet A, Levy C. Face Masks in Young Children During the COVID-19 Pandemic: Parents' and Pediatricians' Point of View. Front Pediatr. 2021 Jun 23;9:676718. doi: 10.3389/fped.2021.676718. eCollection 2021.

  • Alsaleh MM, Sabbarini JM, Al-Batayneh OB, Khader YS. Changes in Behavior Management and Treatment Modalities in Pediatric Dentistry during COVID-19 Pandemic. Int J Clin Pediatr Dent. 2020;13(Suppl 1):S125-S131. doi: 10.5005/jp-journals-10005-1885.

  • Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.

  • Azab MM. Influence of different personal protective equipment on children's anxiety in dental office: a randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):421. doi: 10.1186/s12903-022-02442-5.

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Haluk Bodur, Prof. Dr

    Gazi University Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Pediatric dentistry

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 15, 2025

Study Start

January 2, 2024

Primary Completion

February 3, 2024

Study Completion

November 3, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations