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| ID | Type | Description | Link |
|---|---|---|---|
| 648/2023 | Other Identifier | Suez Canal University |
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| Name | Class |
|---|---|
| Suez Canal University | OTHER |
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The goal of this study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are:
Participants (13 children aged 6-9 years) will:
Receive both devices in a "split-mouth" design (one on each side of the mouth), totaling 26 treated tooth spaces (13 per group).
Attend checkups every 3 months for a year to monitor the devices' performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal Band and loop | Active Comparator | Classic Stainless-steel Band and Loop , Control group |
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| 3d Printed Resin band and loop | Experimental | 3d printed band and loop with the new design , using Permanent Crown resin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3d Printed space maintainer | Device | using Next dent permanent crown resin, a digitally designed space maintainer will be 3d printed to maintain space after extraction |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate of Space Maintainers | Percentage of space maintainers remaining functional without failure Unit of Measure: Percentage of participants | 12 months |
| Gingival health index | measuring Gingival index for both space maintainers to compare the a ability of plaque to attach to both devices. scale 0-3, higher scores indicate worse gingival health | at 3-month follow-up, 6 months follow-up , and 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale | Scale Range: 0 (no hurt) to 10 (hurts worst) Interpretation: Higher scores indicate worse pain/lower satisfaction | immediately after cementation,at 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar A Hodhod | The British University in Egypt , Suez canal university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The British University in Egypt , Pediatric Dentistry Clinic | El Shorouk | Cairo Governorate | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 16, 2023 | Aug 30, 2025 | Prot_SAP_ICF_000.pdf |
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Split Mouth
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| stainless steel band and loop | Device | lab fabricated metal band and loop |
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