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This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional band and loop space maintainer | Active Comparator | Impressions will be taken from the patients with sterilized plastic pedodontic impression trays and alginate under standard conditions by the same researcher. Alginate will be mixed in accordance with the manufacturer's instructions. After the impressions, plaster study casts will be produced and sent to the laboratory. Conventional SMs will be produced by soldering the 0.7-mm bent orthodonic wires (Dentaurum, Germany) onto previously selected prefabricated molar bands. Prefabricated molar bands (Dentaurum, Germany) in the patient's mouth will be chosen by the physician and then sent to the laboratory with the casts. All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey). |
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| 3D printed space maintainer | Experimental | Patients in this group will be scanned under standard conditions with Medit i500 (Medit Corp. Seoul, South Korea). The scanned data of the patients will be sent to the laboratory via email in Standard Triangle Language (STL) file format.The design of SMs will be carried out on the DentalCAD 2.2 Valletta (Exocad GmbH, Darmstadt, Germany) program to mimic the conventional space maintainer, and the production will be made by the 3D Selective laser melting (SLM Solutions, Germany) method using titanium-based metal powder (Ti64 Gd23; LPW Technology Ltd., Cheshire, UK). The production of 3D-SMs will start in accordance with the C-SM design in many points, such as the fit of the part surrounding the abutment tooth, thickness, and the position of the loop of 3D-SM. All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed space maintainer | Other | Digitally fabricated #d printed space maintainer |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival health of the abutment | Gingival index 0 = normal gingiva; 1 = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3 = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding | 0,6,12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya Alaa Abdelaziz Elsayed, Assistant lecturer | Contact | +201090802757 | aya.alaa@dentistry.cu.edu.eg |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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3D printed band and loop space maintainer Conventions band and loop space maintainer
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double blinded
| Conventional space maintainer | Other | Stainless steel space maintains |
|
| Plaque accumulation on the abutment tooth |
Plaque index Score 0: No Plaque Score 1:Thin plaque layer at the gingival margin, only detectable by scraping with a probe Score 2: Moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye Score 3:Abundant plaque along the gingival margin; interdental spaces filled with plaque |
| 0,6,12 months |
| Patients' satisfaction about the impression technique | Five- question survey
| Immediately after the im- pression/scanning |