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

Study Overview
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Brief Summary
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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.

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

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Device: Caries detection method: Intraoral camera
* Device: Caries detection method: Smartphone camera
* Other: Referral pathway: prevention specified
* Other: Referral pathway: no prevention specified


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoral camera, no prevention specified<br> | Device: Caries detection method: Intraoral camera<br>* 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.<br>Other: Referral pathway: no prevention specified<br>* 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.<br>|
| Experimental: Intraoral camera, prevention specified<br> | Device: Caries detection method: Intraoral camera<br>* 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.<br>Other: Referral pathway: prevention specified<br>* 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.<br>|
| Experimental: Smartphone camera, no prevention specified<br> | Device: Caries detection method: Smartphone camera<br>* 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.<br>Other: Referral pathway: no prevention specified<br>* 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.<br>|
| Experimental: Smartphone camera, prevention specified<br> | Device: Caries detection method: Smartphone camera<br>* 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.<br>Other: Referral pathway: prevention specified<br>* 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.<br>|

What is the study measuring?
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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. | up to 12 months |