About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Lower first permanent molar in active state of eruption
Patient and parent showing cooperation and compliance.
Medically free children.
According to space analysis available space is less than or equal to needed space
Disqualifiers
Children with previous allergies to stainless steel.
There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
Trial design
Parallel
Treatments tested in this trial
3D printed space maintainer
Other interventionDigitally fabricated #d printed space maintainer
Conventional space maintainer
Other interventionStainless steel space maintains
Treatment groups
Trial outcomes
Primary outcomes
Survival rate
Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers
Secondary outcomes
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
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
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?"
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: