Evaluation of 3D-printed Space Maintainers Versus Conventional Space Maintainer : a Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D printed space maintainer, Conventional space maintainer.
- Who it may be relevant to
- Registry conditions: Tooth Loss. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of Digitally Fabricated 3D-printed Band and Loop Space Maintainers Versus Conventional Band and Loop Space Maintainer : a Randomized Clinical Trial
Overview
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
- Other 3D printed space maintainer
Digitally fabricated #d printed space maintainer - Other Conventional space maintainer
Stainless steel space maintains
Primary outcome measures
- Survival rate [Time frame: 1 year]
Secondary outcome measures (3)
- Gingival health of the abutment [Time frame: 0,6,12 months]
- Plaque accumulation on the abutment tooth [Time frame: 0,6,12 months]
- Patients' satisfaction about the impression technique [Time frame: Immediately after the im- pression/scanning]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06750068 · 16111992ayaalaaabdelazizelsaye