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Comparative Evaluation of Different Dental Space Maintainers in Children: A Study of Four Interventions (Conventional, Prefabricated, 3D-Printed, and CAD/CAM) in Pediatric Participants

Comparison and evaluation of effectiveness and clinical performance of conventional space maintainer, preformed space maintainer , 3-D printed space maintainer and CAD/CAM space maintainer - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088601
Enrollment
60
Registered
2025-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None listed

Interventions

Intervention1: Conventional Space Maintainer (stainless steel bands/wires, GIC-cemented), Preformed Space Maintainer (prefabricated bands, GIC-cemented), 3D Printed Space Maintainer (digital impressio
uses pliers, soldering
multiple visits. Preformed (Group B): Prefabricated bands (Kids-e-dental ), GIC-cemented
uses band pusher
less chairtime. 3D Printed (Group C): Digital impressions, Digital Light Processing Printer, GIC-cemented. CAD/CAM (Group D): Intraoral scanning (Shining 3-D), Arum Machine, GIC-cemented. Assessed at

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Grossly decayed single molars on either side/single side indicated for extraction. 2.Sound and healthy teeth adjacent to the extraction site 3.Presence of succedaneous tooth bud 4.No abnormal dental conditions such as crossbite, open bite, and deep bite 5.Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one- third of the root formed. 6.Parents who gave consent

Exclusion criteria

Exclusion criteria: 1.Grossly carious tooth adjacent to the extraction site 2.Children whose parents refused to give consent 3.Presence of any systemic disease 4.Absence of teeth on the mesial or distal side of the teeth to be extracted 5.In cases of Space Loss

Design outcomes

Primary

MeasureTime frame
evaluate and compare the clinical effectiveness and survival rate of conventional, preformed, 3D-printed, and CAD/CAM space maintainers in pediatric patients over a 12-month follow-up period. This includes assessment of the appliance s retention, stability, structural integrity, and ability to maintain the space for the eruption of permanent teethTimepoint: Follow up at baseline, 1 month, 6 months, and 12 months—

Secondary

MeasureTime frame
Patient Comfort: Assessed via Likert Scale for patient/parent satisfaction with comfort levels for Conventional, Preformed, 3D Printed, and CAD/CAM space maintainers. Material Durability: Evaluated for structural integrity (e.g., solder breakage, loop breakage, de-cementation) at 1, 6, and 12 months. Gingival Health of Abutment Tooth: Measured using the Loe and Silness Gingival Index (1963) to assess normal, mild, or moderate inflammation at follow-up intervals.Timepoint: 1 month 6 months 12 months—

Countries

India

Contacts

Public ContactSHRIYA

Santosh Deemed to be University

tash_aa@yahoo.com9871966965

Outcome results

None listed

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