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

A Tele-detection and Referral pAthways Model for Early Childhood cariEs Control- a Randomized Factorial Study: The TRACE Study

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.

Study Overview

• Status: Recruiting
• Conditions: Early Childhood Caries
• Intervention / Treatment: Device: Caries detection method: Intraoral camera; Device: Caries detection method: Smartphone camera; Other: Referral pathway: Conventional referral; Other: Referral pathway: User fee removal

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan M Aly, M.Sc; Phone Number: +20 1006639489; Email: nourhan.moustafa@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Recruiting
    • Faculty of Dentistry, Alexandria University
    • Contact: Nourhan M Aly, BDS; Phone Number: (03) 4868308; Email: nourhan.moustafa@alexu.edu.eg
    • Principal Investigator: Nourhan M Aly, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoral camera, conventional referral	Device: Caries detection method: Intraoral camera; 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.; Other: Referral pathway: Conventional referral; 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.
Experimental: Intraoral camera, user fee removal	Device: Caries detection method: Intraoral camera; 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.; Other: Referral pathway: User fee removal; 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.
Experimental: Smartphone camera, conventional referral	Device: Caries detection method: Smartphone camera; 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.; Other: Referral pathway: Conventional referral; 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.
Experimental: Smartphone camera, user fee removal	Device: Caries detection method: Smartphone camera; 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.; Other: Referral pathway: User fee removal; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health-related quality of life	This will be assessedusing the Arabic Version of Early Childhood Oral Health Impact Scale (ECOHIS).The scale comprises 13 items included in two main sections: the Child Impact Section (9 items) and the Family Impact Section (4 items). The Child Impact Section has four domains: child symptom (one item), child function (four items), child psychology (two items) and child self-image and social interaction (two items). The Family Impact Scale has two domains: Parental distress (two items) and Family function (two items). The response options are coded: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often. ECOHIS scores are calculated by summing the response codes for the child and family sections separately. The values range from 0 to 52 for the total scale (0-36 for the child section and 0-16 for the family section). The highest score expressed a greater impact of the state of oral health indicating worse quality of life.	up to 12 months
Procedure time	The time needed for intra-oral scanning and assessing the CAST codes will be recorded per patient, and the average time will be calculated and compared between the two methods.	throughout the procedure completion
The child's behavior during dental photography	This will be assessed through direct observation of the patients and will be assessed on a 5-point Likert scale ranging from "not at all" to "extremely". Higher scores on the positive items indicate favorable behavior	throughout the procedure completion
The child's mood during dental photography	This will be assessed based on the modified "Positive and Negative Affect Schedule" (PANAS) scale through direct observation of the patients and will be assessed on a 5-point Likert scale ranging from "not at all" to "extremely". Higher scores on the positive outcomes indicate a better mood, while lower scores on the negative items indicate a worse mood.	throughout the procedure completion
Percentage of preventive visits completed per child	The number of preventive visits that are attended per child will be assessed.	up to 12 months
Rate of treatment completion	Treatment completion rate will be assessed by monitoring the procedures received out of all procedures the child was indicated to receive.	up to 12 months

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Nourhan M Aly, M.Sc, Alexandria University; Study Chair: Mona K El Kashlan, PhD, Alexandria University; Study Chair: Nicolas Giraudeau, University Hospital Center of Montpellier, France; Study Director: Maha El Tantawi, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: #1-10/7/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No