Tooth Loss
Conditions
Brief summary
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.
Interventions
Digitally fabricated #d printed space maintainer
Stainless steel space maintains
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
double blinded
Intervention model description
3D printed band and loop space maintainer Conventions band and loop space maintainer
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss) * Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 1 year | Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival health of the abutment | 0,6,12 months | 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 | 0,6,12 months | 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 | Immediately after the im- pression/scanning | 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? |
Contacts
Primary ContactAya Alaa Abdelaziz Elsayed, Assistant lecturer
Outcome results
None listed