Skip to content

Comparison of Different Space Maintainers in Children After Early Loss of Milk Teeth

Comparative Evaluation of 3D Printed, Preformed Band with Custom-made Loop and Conventional Band and Loop Space Maintainers in Children: A Randomized Clinical Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111386
Enrollment
75
Registered
2026-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: A digitally designed and 3D printed appliance that provides better precision, improved fit and enhanced patient comfort compared to convention

Sponsors

Dr Mausumi Bharali
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Premature loss or grossly mutilated single primary molar requiring extraction. 2.Sound adjacent teeth suitable for abutment support. 3.Presence of succedaneous permanent tooth bud. 4.At least 1 mm bone coverage over the succedaneous tooth with less than one-third root formation. 5.Cooperative children whose parents are willing to provide informed consent.

Exclusion criteria

Exclusion criteria: 1.Grossly carious abutment teeth. 2.Absence of succedaneous tooth bud. 3.Children with systemic disease or special healthcare needs. 4.Presence of abnormal occlusion such as crossbite, open bite, or deep bite. Children whose parents refuse consent.

Design outcomes

Primary

MeasureTime frame
Evaluation and comparison of the clinical performance and survival rate of conventional band and loop, preformed band with custom-made loop, and 3D printed band and loop space maintainersTimepoint: Evaluated at 1 month, 3 months, 6 months and 9 months.

Secondary

MeasureTime frame
Recording and comparing chairside time for band adaptation, impression procedures, and intraoral scanningTimepoint: During the first clinical appointment.;Comparative evaluation of gingival health and plaque accumulation around abutment teeth.Timepoint: Baseline, 1 month, 3 months, 6 months, and 9 months.;Assessment of patient satisfaction and acceptance using a Likert scale questionnaire.Timepoint: Baseline, 1 month, 3 months, 6 months, and 9 months.;Assessment of the incidence of white spot lesions around abutment teeth.Timepoint: At the 9-month follow-up after appliance removal.

Countries

India

Contacts

Public ContactDr Mausumi Bharali

Saraswati Dental College and hospital, Lucknow

grover.kavita@gmail.com9721222260

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026