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| Name | Class |
|---|---|
| Mahidol University | OTHER |
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The goal of this observational study is to compare the diagnostic performance of three detection methods for approximal carious lesions in primary molars among pediatric patients aged 4-10 years. The study focuses on children in three age groups: 4-6 years, 6-8 years, and 8-10 years. The main questions it aims to answer are:
Researchers will compare the three diagnostic approaches to determine whether age influences diagnostic performance and patient acceptance.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-6 years old |
| ||
| 6-8 years old |
| ||
| 8-10 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bitewing radiograph | Diagnostic Test | Digital radiograph, proximal caries, initial caries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis performance | The diagnostic performance will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter.
| From enrollment to clinical examination on day 7th |
| Age-influenced on diagnostic performance | The diagnostic performance for each age group will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter.
| From enrollment to clinical examination at day 7th |
| Measure | Description | Time Frame |
|---|---|---|
| Children's acceptance | Children's acceptance will be evaluated using the Simplified Facial Pain Scale (S-FPS), which ranges from 0 to 10. The minimum value is 0, representing "no pain", and the maximum value is 10, representing "severe pain". | From enrollment to examination at day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric dental clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sawanya Prutthithaworn, Ph.D. (Dental biomaterials) | Contact | +6622007821 | 25 | sawanya.pru@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus) | Not yet recruiting | Bangkok | 10400 | Thailand |
The individual participant data (IPD), as required by the ethical approval granted by MU-DT/PY-IRB, will remain confidential and will not be disclosed. All data will be reported in aggregate form in publications or reports, ensuring that no individual participant can be identified. Any disclosure beyond these conditions will require an amendment to the approved ethical protocol.
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| Near-infrared light transillumination | Diagnostic Test | DIAGNOcam, proximal caries, initial caries |
|
| Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus) | Recruiting | Bangkok | 10400 | Thailand |
|
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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