Early Childhood CariesNCT06019884
A Tele-detection and Referral Pathways Model for Early Childhood Caries Control
A study testing Caries detection method: Intraoral camera, Caries detection method: Smartphone camera and Referral pathway: User fee removal in people with Early Childhood Caries, run by University of Alexandria at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Caries detection method: Intraoral camera, Caries detection method: Smartphone camera and Referral pathway: User fee removal
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Dec 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age <6 years old with primary dentition only.
- Written consent from the legal guardian
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria, 21512
Nourhan M Aly, BDS, (03) 4868308, nourhan.moustafa@alexu.edu.eg
Nourhan M Aly, MSc
About this study
Official title: 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.
- Conditions
- Early Childhood Caries
- Being tested
- Caries detection method: Intraoral camera, Caries detection method: Smartphone camera, Referral pathway: User fee removal, Referral pathway: Conventional referral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries detection method: Intraoral cameraDevice
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 cameraDevice
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.
Referral pathway: User fee removalOther
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.
Referral pathway: Conventional referralOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral camera, conventional referral | Experimental | Not described Receives: Device: Caries detection method: Intraoral camera; Other: Referral pathway: Conventional referral |
| Intraoral camera, user fee removal | Experimental | Not described Receives: Device: Caries detection method: Intraoral camera; Other: Referral pathway: User fee removal |
| Smartphone camera, conventional referral | Experimental | Not described Receives: Device: Caries detection method: Smartphone camera; Other: Referral pathway: Conventional referral |
| Smartphone camera, user fee removal | Experimental | Not described Receives: Device: Caries detection method: Smartphone camera; Other: Referral pathway: User fee removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: up to 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: throughout the procedure completion
Percentage of preventive visits completed per child
The number of preventive visits that are attended per child will be assessed.
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start23 Dec 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Nourhan M Aly, M.Sc, Principal investigator, Alexandria UniversityMona K El Kashlan, PhD, Study chair, Alexandria UniversityNicolas Giraudeau, Study chair, University Hospital Center of Montpellier, FranceMaha El Tantawi, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019884
- Sponsor's protocol ID
- #1-10/7/2023
- Status last verified
- May 2024
- First submitted
- 23 Aug 2023
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39737579Aly 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.
PubMed 39129017
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tele-detection and Referral pAthways Model for Early Childhood cariEs Control- a Randomized Factorial Study: The TRACE Study
- ClinicalTrials.gov ID
- NCT06019884
- Acronym / sponsor ID
- #1-10/7/2023
- Conditions
- Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age <6 years old with primary dentition only.
- Written consent from the legal guardian
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caries detection method: Intraoral cameraA 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. | Device | Intraoral camera, conventional referral, Intraoral camera, user fee removal |
| Caries detection method: Smartphone cameraThis 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. | Device | Smartphone camera, conventional referral, Smartphone camera, user fee removal |
| Referral pathway: User fee removalThe 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. | Other | Intraoral camera, user fee removal, Smartphone camera, user fee removal |
| Referral pathway: Conventional referralChildren 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. | Other | Intraoral camera, conventional referral, Smartphone camera, conventional referral |
Primary outcome
The percentage of teeth receiving care
Time frame: up to 12 months
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".
6 secondary outcomes
Oral health-related quality of life
Time frame: up to 12 months
Procedure time
Time frame: throughout the procedure completion
The child's behavior during dental photography
Time frame: throughout the procedure completion
The child's mood during dental photography
Time frame: throughout the procedure completion
Percentage of preventive visits completed per child
Time frame: up to 12 months
Rate of treatment completion
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 39737579Aly 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.
- Derived from this study: PubMed 39129017Aly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nourhan M Aly, M.Sc principal investigator
Alexandria University
Mona K El Kashlan, PhD study chair
Alexandria University
Nicolas Giraudeau study chair
University Hospital Center of Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caries detection method: Intraoral camera, Caries detection method: Smartphone camera and Referral pathway: User fee removal in people with Early Childhood Caries, run by University of Alexandria at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan M Aly, M.Sc (1006639489 ext. +20, nourhan.moustafa@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of teeth receiving care (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019884, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.