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Comparison of Band & loop space maintainer fabricated by 3 different techniques in children of 5-9 years.

Comparative evaluation of the clinical and radiographic effectiveness of 3D printed, pre-fabricated, and conventional band and loop space maintainers in children aged 5-9 years- A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068337
Enrollment
36
Registered
2024-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 3D printed band and loop space maintainer: 3D printed space maintainer will be fabricated using digital light printing. After extraction , digital impression on the first appointment th

Sponsors

Dr Nupur Ninawe
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children between ages 5-9 years old showing Frankl Behavioural Rating scale scores of 3 and 4 primary molar loss in the last one week due to caries, periapical infection, and resorption to eliminate possible space loss The presence of the successor tooth germ to justify the use of band and loop space maintainer at least 1 year for the successor tooth to erupt to ensure that the band and loop space maintainer remain in the mouth until the end of the study. Presence of adequate post-extraction space for the unhindered eruption of the successor tooth. No symptoms of pulpal pathology in the abutment teeth that will support band and loop space maintainer to prevent possible abutment tooth loss class I occlusion and no skeletal anomaly to prevent abnormal occlusal forces. only one tooth loss in the same quadrant to confirm the indication for a fixed band and loop space maintainer. For 3D printed Band and loop space maintainer, permanent molar should not be erupted. Parents or caretakers who are willing to participate in this study.

Exclusion criteria

Exclusion criteria: Children showing Frankl Behavioural Rating scale scores 1 and 2. Children with systemic diseases or children who require special health care needs. Children with a history of systemic antibiotics or any medication in the last 3 months. More than 2 weeks since tooth loss to eliminate possible space loss Less than one year left for the permanent tooth to erupt tooth to prevent possible abutment tooth loss

Design outcomes

Primary

MeasureTime frame
Clinical,radiological , retentive and periodontal evaluation of 3D printed conventional and prefabricated band and loop space maintainerTimepoint: 1 and 3 months

Secondary

MeasureTime frame
Clinical,radiological , retentive and periodontal evaluation of 3D printed conventional and prefabricated band and loop space maintainerTimepoint: 6 and 9 months

Countries

India

Contacts

Public ContactDr Nupur Ninawe
snehaljagtapoppo4@gmail.com07350928844

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026