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
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.
Status | Recruiting |
Enrollment | 480 |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
University of Alexandria |
Egypt,
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 ranging from "not at all" to "extremely". Higher scores on the positive items indicate favorable behavior | throughout the procedure completion | |
Secondary | 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 | |
Secondary | Percentage of preventive visits completed per child | The number of preventive visits that are attended per child will be assessed. | up to 12 months | |
Secondary | 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 |
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