An interventional study of 3D printed space maintainer and Conventional space maintainer in Tooth Loss, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Cairo University · Not applicable, Interventional, and Other
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
Other: Conventional space maintainer
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).
Other: 3D printed space maintainer
Digitally fabricated #d printed space maintainer
Stainless steel space maintains
Survival rate
Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers
Time frame: 1 year
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
Time frame: 0,6,12 months
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
Time frame: 0,6,12 months
Patients' satisfaction about the impression technique
Five- question survey 1. "Was the impression easy and fun?" 2. "Did you have nausea during impression?" 3. "Did you feel any discomfort during the impression (taste, odor, foreign body)?" 4. "Did the impression take a short time?" 5. "Would you like to have this impression experience again?"
Time frame: Immediately after the im- pression/scanning
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Jun 2025, 2 months later.
Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 2 months is below that.
Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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