A Tele-detection and Referral Pathways Model for Early Childhood Caries Control

University of Alexandria

Status: Enrolling

Conditions: Early Childhood Caries

Treatments: Device: Caries detection method: Smartphone camera; Other: Referral pathway: User fee removal; Other: Referral pathway: Conventional referral; Device: Caries detection method: Intraoral camera

Study type: Interventional

Funder types: Other

Identifiers

NCT06019884

#1-10/7/2023

Details and patient eligibility

About

The aim of the study is to assess the effectiveness of ECC tele-detection methods combined with referral pathways, with and without user fee removal, in controlling ECC.

Enrollment: 480 estimated patients

Sex: All

Ages: Under 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age <6 years old with primary dentition only.
• Written consent from the legal guardian

Exclusion criteria

• Children above 6 years old.
• Children with mixed or permanent dentitions.
• Children with physical disabilities or psychiatric disorders.
• Children with intellectual disabilities.
• Children indicated for dental treatment under general anesthesia

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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480 participants in 4 patient groups

Intraoral camera, conventional referral

Experimental group

Treatment:

Device: Caries detection method: Intraoral camera

Other: Referral pathway: Conventional referral

Intraoral camera, user fee removal

Experimental group

Treatment:

Device: Caries detection method: Intraoral camera

Other: Referral pathway: User fee removal

Smartphone camera, conventional referral

Experimental group

Treatment:

Other: Referral pathway: Conventional referral

Device: Caries detection method: Smartphone camera

Smartphone camera, user fee removal

Experimental group

Treatment:

Device: Caries detection method: Smartphone camera

Other: Referral pathway: User fee removal