Comparison of esthetic and metal space maintainers used in children after early loss of milk teeth

Comparative Evaluation of clinical efficacy of Novel Esthetic Versus Conventional Space Maintainers A Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100763

Enrollment

Registered

2026-01-09

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: R688- Other general symptoms and signs

Interventions

Intervention1: 3D-printed Novel Esthetic Space Maintainers: 3D printed space maintainers fabricated using CAD/CAM technology, offering esthetic benefits, comfort and improved fit designed to preserve

Eligibility

Inclusion criteria

Inclusion criteria: Clinical Inclusion Criteria: Systemically healthy children (aged 4 7 years). Children with early loss of primary 1st molars in both maxillary and mandibular arches. Angles Class 1 occlusion and normal primary molar relation. No abnormal dental conditions such as cross, open, and deep bite. Radiographic Inclusion Criteria: Bone covering of at least 1mm over the succedaneous tooth germ

Exclusion criteria

Exclusion criteria: Clinical Exclusion Criteria: Grossly carious teeth adjacent to the teeth to be extracted. Absence of teeth on the mesial or distal side of the teeth to be extracted. Patient having any systemic disease. Radiographic Exclusion Criteria: Absence of succedaneous tooth bud.

Design outcomes

Primary

Measure	Time frame
Clinical success and failure rate of space maintainers (retention, debonding, modes of failure) measured across the three groupsTimepoint: Baseline T0 before space maintainer placement Post procedure T1 Immediately after space maintainer insertion Follow up T2 At 1, 3, 6 months after space maintainer insertion	—

Secondary

Measure	Time frame
Gingival health and plaque accumulation scores using Gingival Index and Plaque IndexTimepoint: Baseline T0 before space maintainer placement Post procedure T1 Immediately after space maintainer insertion Follow up T2 At 1, 3, 6 months after space maintainer insertion;Emotional Impact and anxiety levelsTimepoint: Baseline T0 before space maintainer placement Post procedure T1 Immediately after space maintainer insertion Follow up T2 At 1, 3, 6 months after space maintainer insertion	—

Measure

Time frame

Gingival health and plaque accumulation scores using Gingival Index and Plaque IndexTimepoint: Baseline T0 before space maintainer placement Post procedure T1 Immediately after space maintainer insertion Follow up T2 At 1, 3, 6 months after space maintainer insertion;Emotional Impact and anxiety levelsTimepoint: Baseline T0 before space maintainer placement Post procedure T1 Immediately after space maintainer insertion Follow up T2 At 1, 3, 6 months after space maintainer insertion

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Countries

India

Contacts

Public ContactGeetanjali Mahajan

Saveetha Dental College and Hospitals, SIMATS University, Chennai

poojavr.sdc@saveetha.com8940844133

Outcome results

None listed

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