Comparative evaluation of 3D Zirconia vs Prefabricated Band and loop space maintainers in children aged 4-10 years

Comparative Evaluation of Clinical Outcomes of Band and loop Space Maintainers: Prefabricated vs 3D Designed Zirconia in Children of Aged 4-10 years Randomised Controlled Trial (Academic Trial) - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093067

Enrollment

Registered

2025-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: 3D Designed Zirconia: Digital impression of the dental arch is acquired using intraoral scanner, exported to the computer-aided design (CAD) software as an STL file, printed using pre s

Eligibility

Inclusion criteria

Inclusion criteria: CLINICAL CRITERIA: 1.Child within the age group of 4-10 2.Single primary tooth loss requiring space maintenance programme 3.Otherwise healthy children 4.Sound abutment teeth RADIOGRAPHIC CRITERIA: 5.Presence of succedaneous tooth 6.Presence of more than 1mm bone covering succedaneous tooth radiographically 7.Less than two-thirds of root formation with succedaneous tooth.(Up to Nollas stage 8)

Exclusion criteria

Exclusion criteria: 1.Children with known systematic illness contraindicating placement of band and loop space maintainer 2.Grossly decayed abutment teeth 3.Cases requiring long band and loop space maintainer 4.High caries index 5.Children with poor oral hygiene 6.Multiple carious teeth in same quadrant 7.Prolonged loss of teeth which may need for any space regaining schedule 8.Abnormal sequence of eruption 9.Patient with developing class II and class III malocclusion 10.Presence or anticipated arch length and tooth size discrepancy 11.Otherwise abnormal functional and muscular oral activity

Design outcomes

Primary

Measure	Time frame
To evaluate space maintenance efficiency of 3D Designed space maintainer versus Prefabricated band and loop space maintainer assessed by comparing the mesiodistal spaces pre- and post- 9 months follow-up (3, 6, 9 months) taken from intraoral scans. Timepoint: At the time of procedure, At 3 months, At 6 months, At 9 months.	—

Secondary

Measure	Time frame
To analyse survival rates of other clinical outcomes (De-cementation, Loop Breakage, Band Breakage, & Secondary Caries) over 9 months (3, 6, 9 months).Timepoint: At the time of procedure, At 3 months, At 6 months, At 9 months. ;To evaluate most common type of failure associated with 3D Designed band & loop space maintainer & prefabricated band & loop space maintainer over 9 months(3, 6, 9 months).Timepoint: At the time of procedure, At 3 months, At 6 months, At 9 months.	—

Measure

Time frame

To analyse survival rates of other clinical outcomes (De-cementation, Loop Breakage, Band Breakage, & Secondary Caries) over 9 months (3, 6, 9 months).Timepoint: At the time of procedure, At 3 months, At 6 months, At 9 months. ;To evaluate most common type of failure associated with 3D Designed band & loop space maintainer & prefabricated band & loop space maintainer over 9 months(3, 6, 9 months).Timepoint: At the time of procedure, At 3 months, At 6 months, At 9 months.

—

Countries

India

Contacts

Public ContactGinjupalli Laharee

AIIMS MANGALAGIRI

drjayam.dental@aiimsmangalagiri.edu.in8894337313

Outcome results

None listed

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