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3D printed space maintainer (3D-SM) vs. traditional band and loop space maintainer (C-BLSM)

Effectiveness of 3D printed space maintainer Vs traditional Bond and loop space maintainer following loss of primary teeth. A randomized clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054553
Enrollment
30
Registered
2023-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K006- Disturbances in tooth eruption

Interventions

Intervention1: 3D Printed Space Maintainer: The 3D printed space maintainer (3D-SM) is a novel device that can be custom-designed and fabricated in a single visit. The placement will be done and will

Sponsors

Dr Anuj Bhardwaj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria Clinical criteria Systemically healthy children. Grossly mutilated single molars on either side, requiring extraction. Freshly extracted single molars bilaterally in the same arch or opposite arch. Sound and healthy teeth adjacent to the extraction site. No abnormal dental conditions such as crossbite, open bite, and deep bite. Radiographic criteria Presence of succedaneous tooth bud. Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one-third of the root formed.

Exclusion criteria

Exclusion criteria: Grossly carious teeth were adjacent to the created space. Absence of teeth on the mesial or distal side of the teeth to be extracted.

Design outcomes

Primary

MeasureTime frame
Survival Time of Space maintainers compared Gingival Health of the Abutment Tooth Timepoint: follow up intervals 0 1 3 6 and 9 months

Secondary

MeasureTime frame
Patient SatisfactionTimepoint: follow up intervals 0 1 3 6 and 9 months

Countries

India

Contacts

Public ContactAnuj Bhardwaj

College of Dental Sciences and Hospital

dranuj_84@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026