NCT07656948

Brief Summary

This randomized controlled trial aimed to evaluate the effect of a brief teledentistry consultation on dental anxiety in children aged 7-11 years. Two hundred children with no previous dental visits or treatment experience were randomly assigned to either a teledentistry group or a conventional clinical examination group. The teledentistry group received a standardized 3-5-minute pre-appointment video consultation via WhatsApp before their first dental visit. Dental anxiety was assessed using subjective and physiological parameters before and after the examination. The study investigated whether teledentistry could reduce dental anxiety and improve children's adaptation to their first dental visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

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

September 11, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

TeledentistryPediatric DentistryDental AnxietyChildFacial Image ScaleFirst Dental VisitPulse OximetryHeart Rate

Outcome Measures

Primary Outcomes (3)

  • Subjective dental anxiety in children

    Dental anxiety levels of children assessed before and after the first dental examination using the Facial Image Scale (FIS).

    Before and immediately after the first dental examination (same day)

  • Objective dental anxiety assessed by oxygen saturation

    Peripheral oxygen saturation (SpO2) was measured before and immediately after the first dental examination as an objective physiological parameter of dental anxiety.

    Before and immediately after the first dental examination (same day)

  • Objective dental anxiety assessed by heart rate

    Heart rate was measured before and immediately after the first dental examination as an objective physiological parameter of dental anxiety.

    Before and immediately after the first dental examination (same day)

Study Arms (2)

Teledentistry Group

EXPERIMENTAL

Participants received a standardized 3-5-minute synchronous teledentistry consultation via WhatsApp before their first dental examination. Children were introduced to the dentist, dental instruments, oral health concepts, and the examination process.

Behavioral: Teledentistry Consultation

Conventional Clinical Examination Group

ACTIVE COMPARATOR

Participants underwent a conventional face-to-face clinical examination without prior teledentistry consultation. Children met the pediatric dentist for the first time during their scheduled dental appointment and received a routine clinical examination.

Other: Conventional Clinical Examination

Interventions

A standardized synchronous teledentistry consultation delivered via WhatsApp for 3-5 minutes before the first dental examination. Children were introduced to the dentist, dental instruments, oral health concepts, and the examination process.

Teledentistry Group

Participants underwent a routine face-to-face dental examination without prior teledentistry consultation. Children attended their first dental visit and received a standard clinical examination performed by a pediatric dentist.

Conventional Clinical Examination Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7 to 11 years.
  • Children attending their first dental examination appointment.
  • Children requiring a non-emergency dental examination.
  • Children and their parents/legal guardians who provided written informed consent.

You may not qualify if:

  • Children with previous dental treatment experience.
  • Children with systemic diseases, neurological disorders, or developmental disabilities that could affect anxiety assessment.
  • Children requiring emergency dental treatment.
  • Children whose parents/legal guardians did not provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Kucukcekmece, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups: a teledentistry group and a conventional clinical examination group in a 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Istanbul Aydin University

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 18, 2026

Study Start

September 11, 2023

Primary Completion

July 23, 2024

Study Completion

September 27, 2024

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations