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

Early Childhood Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019884
• Other study ID #: #1-10/7/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2023
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of Alexandria
• Contact: Nourhan M Aly, M.Sc
• Phone: 1006639489
• Email: nourhan.moustafa[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to assess the effectiveness of different early childhood caries (ECC) tele-detection methods combined with referral pathways with and without preventive focus in controlling ECC based on clinically assessed and patient-reported oral health outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 868
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

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.
• 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: prevention specified
Child identified at higher risk using the The International Caries Classification and Management System (ICCMS) classification due to the presence of caries experience will be referred with explicit inclusion of preventive care using professionally applied fluoride. The children will also be referred to restorative care or pulp therapy depending on their needs.
• Referral pathway: no prevention specified
This follows the standard practice adopted in dental clinics in public facilities. Care is planned by the receiving dentist, based on available resources, and hospital/ clinic policies. The screening/ sending dentist will inform the family of the oral health condition for which the child needs care and of available public and private facilities that offer this care. The management plan will not be predetermined, and decisions are left to the receiving dentists without explicit mention of the need for preventive care to control ECC.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.	throughout the procedure completion
Secondary	The child's mood during dental photography	This will be assessed through direct observation of the patients and will be assessed on a 5-point Likert scale based on the modified Positive and Negative Affect Schedule (PANAS) scale	throughout the procedure completion