NCT07626008

Brief Summary

Dental anxiety is common in children and may increase during local anesthesia administration. Dental injection anxiety is one of the most frequently reported causes of dental anxiety in pediatric dental patients. Communication-based behavior guidance techniques are commonly used to reduce anxiety during dental procedures. Among these techniques, tell-show-do is widely used in pediatric dentistry and is generally accepted by parents. This completed interventional study evaluated the effect of introducing the syringe and related injection equipment using the tell-show-do technique on dental anxiety during local anesthesia administration in school-aged children. Children aged 5 to 7 years who required dental treatment under buccal infiltration local anesthesia and had no previous dental treatment experience involving injection were enrolled after parental consent was obtained. The study used a controlled within-subject design. Each child attended an adaptation appointment followed by two dental treatment appointments involving local anesthesia. The syringe and related equipment were introduced using the tell-show-do technique at one local anesthesia appointment, whereas the injection equipment was kept out of the child's field of vision at the other local anesthesia appointment. The order of exposure to the tell-show-do intervention differed between sequence groups. Dental anxiety, behavior, and pain-related responses were assessed using validated scales, including the Facial Image Scale, Human Figure Drawing scale, Frankl Behavior Scale, Modified Frankl Behavior Scale, and Sound-Eye-Motor scale. Parent-reported child dental fear and parental dental anxiety were also recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
Last Updated

June 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

May 23, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

Tell-show-dodental anxietylocal anesthesia

Outcome Measures

Primary Outcomes (1)

  • State Dental Anxiety Assessed by the Facial Image Scale

    State dental anxiety after local anesthesia administration was assessed using the Facial Image Scale. The Facial Image Scale is a self-report scale consisting of five faces ranging from very happy to very unhappy. Scores range from 1 to 5, with higher scores indicating greater state dental anxiety.

    Immediately after local anesthesia administration at each injection-related visit, over the 3-month study period.

Secondary Outcomes (5)

  • Child Cooperation Assessed by the Modified Frankl Behavior Scale

    During local anesthesia administration at each injection-related visit, over the 3-month study period.

  • Pain-Related Response Assessed by the Sound-Eye-Motor Scale

    Before, during, and after local anesthesia administration at each injection-related visit, over the 3-month study period.

  • Parent-Reported Child Dental Fear Assessed by the Children's Fear Survey Schedule-Dental Subscale

    At the adaptation appointment before the injection-related visits.

  • Trait Dental Anxiety Assessed by the Human Figure Drawing Scale

    At the adaptation appointment and at the end of each injection-related visit, over the 3-month study period.

  • Child Behavior Assessed by the Frankl Behavior Rating Scale

    During the adaptation appointment before the injection-related visits.

Study Arms (2)

Early Tell-Show-Do Dental Injector Demonstration Sequence

EXPERIMENTAL

Participants in this arm received the tell-show-do dental injector demonstration at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were kept outside the child's field of vision before and during local anesthesia administration.

Behavioral: Early Tell-Show-Do Dental Injector Demonstration Sequence

Delayed Tell-Show-Do Dental Injector Demonstration Sequence

ACTIVE COMPARATOR

Participants in this arm first received local anesthesia with the dental injector and related equipment kept outside the child's field of vision. At the subsequent injection-related visit, the dental injector and related equipment were introduced using the tell-show-do technique before local anesthesia administration.

Behavioral: Delayed Tell-Show-Do Dental Injector Demonstration Sequence

Interventions

This behavioral intervention sequence consisted of introducing the dental injector and related equipment using the tell-show-do technique before local anesthesia administration at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were kept outside the child's field of vision before and during local anesthesia administration.

Early Tell-Show-Do Dental Injector Demonstration Sequence

This behavioral intervention sequence consisted of local anesthesia administration with the dental injector and related equipment kept outside the child's field of vision at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were introduced using the tell-show-do technique before local anesthesia administration.

Delayed Tell-Show-Do Dental Injector Demonstration Sequence

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children requiring dental treatment under buccal infiltration local anesthesia

You may not qualify if:

  • Children whose parents/legal guardians refuse to sign the informed consent form
  • Children whose parents/legal guardians do not consent to the demonstration of the dental injector
  • Children requiring emergency treatment
  • Children with special healthcare needs
  • Children with a history of previous dental treatment performed under local anesthesia via injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Mustafa Sarp Kaya, DDS, PhD

    Bezmialem Vakif University Department of Pediatric Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: This study used a two-sequence crossover design. Participants were assigned to either an early tell-show-do dental injector demonstration sequence or a delayed tell-show-do dental injector demonstration sequence. Each participant underwent two injection-related visits: one visit with tell-show-do dental injector demonstration before local anesthesia administration and one visit with the dental injector kept outside the child's field of vision. The order of these two conditions differed between the study arms, allowing each participant to serve as an internal control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 4, 2026

Study Start

September 1, 2022

Primary Completion

November 28, 2022

Study Completion

May 15, 2023

Last Updated

June 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations