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

NCT06019884 | Recruiting

• 1 other identifier: #1-10/7/2023
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

• The percentage of teeth receiving care

  This will be assessed using the Caries Assessment Spectrum and Treatment (CAST) index. The CAST index hierarchically describes the full spectrum of caries from the absence of caries, passing through prevention (sealants) and treatment (restoration), to the presence of carious lesions with their complications (pulp exposure, abscess/fistula, and tooth loss). As for the condition severity, Codes 0-2 represent "healthy", 3 indicates "pre-morbidity", while 4-5 indicate "morbidity", 6-7 indicate "serious morbidity", and 8 indicates "mortality".

  up to 12 months

Secondary Outcomes (6)

• Oral health-related quality of life

  up to 12 months

• Procedure time

  throughout the procedure completion

• The child's behavior during dental photography

  throughout the procedure completion

• The child's mood during dental photography

  throughout the procedure completion

• Percentage of preventive visits completed per child

  up to 12 months

Study Arms (4)

Intraoral camera, conventional referral

EXPERIMENTAL

Device: Caries detection method: Intraoral camera; Other: Referral pathway: Conventional referral

Intraoral camera, user fee removal

EXPERIMENTAL

Device: Caries detection method: Intraoral camera; Other: Referral pathway: User fee removal

Smartphone camera, conventional referral

EXPERIMENTAL

Device: Caries detection method: Smartphone camera; Other: Referral pathway: Conventional referral

Smartphone camera, user fee removal

EXPERIMENTAL

Device: Caries detection method: Smartphone camera; Other: Referral pathway: User fee removal

Interventions

Caries detection method: Intraoral camera DEVICE

A specialized intraoral camera (C50) with fluorescence signal and selective chromatic amplification will be used to record intraoral structures in the form of videos and/or photos. The camera has four modes (Daylight, Daylight+, Perio and Caries modes) which can differentiate the color of tissues to provide a reliable diagnosis. The camera will be used in a systemic sequence to video record and capture photos of intraoral conditions in both arches. The intraoral camera will be connected to a laptop screen, and the captured videos and/ or photos will be transferred to an electronic platform.

Intraoral camera, conventional referral; Intraoral camera, user fee removal

Caries detection method: Smartphone camera DEVICE

This is a low-cost electronic system consisting of a smartphone positioned in front of the oral cavity to scan the upper and lower jaws from the cheek then the tongue sides. The smartphone camera resolution should be sensitive enough to capture the intraoral structures (at least 1000 pixels). The focus will be adjusted, and the inbuilt flash will be used to obtain clear and sharp images. The photos will be transferred to the electronic platform.

Smartphone camera, conventional referral; Smartphone camera, user fee removal

Referral pathway: User fee removal OTHER

The child's parent/ legal guardian will receive financial incentives. These a are designed to cover the costs of treatment and transportation and are tied to attending the preventive dental visit. The child will receive complete dental care.

Intraoral camera, user fee removal; Smartphone camera, user fee removal

Referral pathway: Conventional referral OTHER

Children will be referred without providing financial incentives following the current standard of care in dental clinics in the public sector in Egypt. Care is planned by the receiving/ treating dentist, based on available resources, and hospital/ clinic policies. The screening/ sending dentist will inform the family about the oral health condition/s and planned treatment costs for which the child needs care and of available public and private facilities that offer the required care.

Intraoral camera, conventional referral; Smartphone camera, conventional referral

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

RECRUITING

Related Publications (2)

• Aly NM, El Kashlan MK, Giraudeau N, El Tantawi M. Children's Acceptance of Intraoral Cameras and Smartphones for Caries Detection: A Randomized Controlled Clinical Trial. Int J Paediatr Dent. 2025 Jul;35(4):792-799. doi: 10.1111/ipd.13291. Epub 2024 Dec 31.

  PMID: 39737579 DERIVED

• Aly NM, El Kashlan MK, Giraudeau N, El Tantawi M. A Tele-detection and referral pAthways model for early childhood cariEs control- a protocol for a randomized factorial study: the TRACE study. BMC Oral Health. 2024 Aug 11;24(1):934. doi: 10.1186/s12903-024-04706-8.

  PMID: 39129017 DERIVED

Study Officials

• Nourhan M Aly, M.Sc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Mona K El Kashlan, PhD

  Alexandria University

  STUDY CHAIR

• Nicolas Giraudeau

  University Hospital Center of Montpellier, France

  STUDY CHAIR

• Maha El Tantawi, PhD

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Nourhan M Aly, M.Sc

CONTACT

1006639489; nourhan.moustafa@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 31, 2023
• Study Start: December 23, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

EG (1)