NCT07571421

Brief Summary

This study evaluated whether a visual educational intervention could reduce dental anxiety in children. During the COVID-19 pandemic, changes in the dental environment, including the use of personal protective equipment, may have increased anxiety levels in pediatric patients. A total of 70 children aged 5 to 14 years were randomly assigned to either a study group that received a visual educational introduction to the dental environment or a control group that received standard care. Dental anxiety was assessed using validated scales and pulse rate measurements. The results showed that children who received the visual educational intervention had lower anxiety levels and reduced physiological stress compared to the control group. The effect was more pronounced in older children, suggesting that age and cognitive development play an important role in the effectiveness of such interventions. Overall, this simple and non-invasive approach may help reduce dental anxiety in children and improve their experience during dental visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 22, 2026

Last Update Submit

April 29, 2026

Conditions

Dental Anxiety in Children

Keywords

COVID-19; dental anxiety; pediatric dentistry; heart rate; patient education; randomized controlled trial.

Outcome Measures

Primary Outcomes (2)

  • Self-Reported Dental Anxiety (MCDASf)

    Dental anxiety was assessed using the faces version of the Modified Child Dental Anxiety Scale (MCDASf). The scale consists of 8 items scored from 1 to 5, with a total score range of 8 to 40. Higher scores indicate greater levels of dental anxiety.

    Immediately before dental treatment (pre-treatment assessment)

  • Self-Reported Dental Anxiety (FIS)

    Dental anxiety was assessed using the Facial Image Scale (FIS), which consists of 5 facial expressions scored from 1 (very happy) to 5 (very unhappy). Higher scores indicate greater levels of anxiety.

    Immediately before dental treatment (pre-treatment assessment)

Secondary Outcomes (1)

  • Physiological Anxiety Response (Pulse Rate)

    Immediately before dental treatment (pre-treatment assessment)

Study Arms (2)

Visual Educational Intervention Group

EXPERIMENTAL

Participants received a visual educational leaflet introducing the dental environment and personal protective equipment before treatment.

Behavioral: Visual Educational Leaflet

Control group

NO INTERVENTION

Participants received standard clinical care without any additional preparatory intervention before treatment.

Interventions

Visual Educational LeafletBEHAVIORAL

A structured visual educational leaflet designed to familiarise children with the dental clinical environment and personal protective equipment. The material included child-friendly images of dental staff, equipment, and procedures to reduce anticipatory dental anxiety.

Visual Educational Intervention Group

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5 to 14 years
  • Requiring restorative dental treatment
  • No systemic disease
  • No mental or physical disabilities
  • Not using medications that could affect anxiety assessment
  • Having previous dental experience (i.e., not first dental visit)

You may not qualify if:

  • Children attending their first dental visit
  • Children with a documented history of definitely negative or negative behavior (Frankl score 1-2)
  • Participants with incomplete data
  • Participants who withdrew consent at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, 34188, Turkey (Türkiye)

Location

Related Publications (3)

  • Cirio S, Salerno C, Mbanefo S, Oberti L, Paniura L, Campus G, Cagetti MG. Use of Visual Pedagogy to Help Children with ASDs Facing the First Dental Examination: A Randomized Controlled Trial. Children (Basel). 2022 May 16;9(5):729. doi: 10.3390/children9050729.

    PMID: 35626906BACKGROUND

  • Dogan MC, Seydaoglu G, Uguz S, Inanc BY. The effect of age, gender and socio-economic factors on perceived dental anxiety determined by a modified scale in children. Oral Health Prev Dent. 2006;4(4):235-41.

    PMID: 17153645BACKGROUND

  • Giri S, Saha S, Dhinsa K, Yadav G, Sharma A, Pradhan S. Comparative Evaluation of Behavioral and Physiological Outcomes on Dental Anxiety of Children Undergoing Dental Treatment: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2025 Apr;18(4):383-393. doi: 10.5005/jp-journals-10005-3088. Epub 2025 May 19.

    PMID: 40469821BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Arzu P Erdem, Principle Investigator

    Istanbul University Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment was performed by a trained paediatric dentist who was blinded to group allocation. Participants and investigators were not blinded due to the nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to either a visual educational intervention group or a control group receiving standard care. The two groups were followed in parallel and compared in terms of dental anxiety outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 6, 2026

Study Start

March 1, 2021

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and privacy considerations, as the study involves pediatric participants and consent for data sharing was not obtained.

Locations

TU(1)