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The primary aim of this study is to introduce a new effective and efficient 3D printed design of an intra-oral space maintainer.
The secondary aim of the study is to:
Evaluate the clinical performance of 3D printed space maintainer versus conventional metal band and loop over a period of 6 months regarding their functional , biological aspects and patient satisfaction.
And will be conducted as follows:
Group 1: Children with 3D printed space maintainer (n=15) Group 2: Children with conventional band and loop(n=15)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Children with 3D printed space maintainer | Experimental |
| |
| Group 2: Children with conventional band and loop | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed space maintainer by NextDent Ortho Rigid | Device | Biocompatible 3D printing material |
|
| Measure | Description | Time Frame |
|---|---|---|
| introduce a new 3D printed design of an intraoral space maintainer. | The function of the new intraoral space maintainer will be assessed whether good retention is obtained or not,by checking whether it fell off the patient's mouth or not . | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects. | Biologically, the oral hygiene of the patient will be assessed by measuring the plaque and the gingival indices scores on the corresponding teeth on a scale from 0-3 | 6 months |
| compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farah Barakat, BDs | Contact | +201009887115 | farah.barakat@bue.edu.eg | |
| Islam Abbas, Phd | Contact | +201005111111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| Conventional Band and Loop | Device | metal space maintainer |
|
Patient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3) |
| 6 months |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |