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Comparing New Types of Dental Space Maintainers for Kids: A Study Using Different Approaches on Each Side of the Mouth

A Novel Fixed Functional Space Maintainer - A Split-mouth study. - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070177
Enrollment
60
Registered
2024-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Band and loop space maintainer: Conventional band and loop space maintainer will be fabricated for the extraction space Control Intervention1: Double band and pontic space maintainer: D

Sponsors

Dr Priyanka B
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 7-9 years requiring extraction of a primary second molar bilaterally/contralaterally. 2.Permanent successor of the extracted tooth in Nolla’s stage 6 or 7. 3.Teeth requiring extraction due to resorbed roots, multiple pulpectomy failures, long-standing infection, or chronic abscess, untreatable endodontically, and poor prognosis. 4.At least 2 mm of bone coverage above the permanent successor must be present.

Exclusion criteria

Exclusion criteria: 1.Congenitally absent permanent successor. 2.Permanent tooth nearing eruption. 3.Children with malocclusion or space loss. 4.Medically compromised or special needs children.

Design outcomes

Primary

MeasureTime frame
1.CLINICAL CRITERIA: A.The gingival index score will be obtained for the banded abutment and evaluated. B.Survival rate and longevity assessed for debonding, fracutre of soldered points and evaluated. C.The pre and post operative extraction space will be analysed and recored. D.The Almond crunch test score (0-3) will be scored based on chewing efficiency . E.Parental acceptance for esthetics and function will be analysed using five point Likert scale. Timepoint: baseline, 3, 6, and 12 months

Secondary

MeasureTime frame
Presence of eruption disturbance of permanent successor using radiographs will be evaluated.Timepoint: at 3, 6, 9, and 12 months interval

Countries

India

Contacts

Public ContactDr Priyanka B

Chettinad Dental College and Research Institute

dayaswathi@gmail.com9884476385

Outcome results

None listed

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