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Comparative evaluation of three different band and loop space maintainers

Comparative evaluation of Conventional, Preformed and Three-dimensional (3D) printed band and loop space maintainers: A Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070238
Enrollment
45
Registered
2024-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K08- Other disorders of teeth and supporting structures

Interventions

Intervention1: Preformed band and loop space maintainers: Preformed band and loop space maintainers are made of prefabricated band with tube attached to it and a U loop of appropriate diameter Interve

Sponsors

Dr Shaikh Misbah Siraj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Systemically healthy and cooperative children. 2. Children with grossly carious primary mandibular first molar of either side requiring extraction 3. Sound and healthy adjacent teeth â?? primary mandibular canine and second molar. 4. Flush and mesial step terminal plane relationship with primary molars and Angleâ??s class I with permanent mandibular first molars if erupted.

Exclusion criteria

Exclusion criteria: 1. Anxious, uncooperative children who require sedation or general anesthesia. 2. Children with abnormalities like deep bite, crossbite, open bite. 3. Children with known allergy to metals like stainless steel or cobalt-chromium.

Design outcomes

Primary

MeasureTime frame
Comparative evaluation of survival and failure rates and gingival health after giving conventional, preformed and three-dimensional (3D) printed B&L space maintainers over a period of 12 months, and to compare patientâ??s comfort, gag reflex, pain and respiratory difficulty during impression making in conventional and three-dimensional (3D) printed band and loop space maintainers.Timepoint: Over a period of 1, 3, 6, 9 and 12 months

Secondary

MeasureTime frame
To compare patientâ??s comfort, gag reflex, pain and respiratory difficulty during impression making in conventional and three-dimensional (3D) printed band and loop space maintainers.Timepoint: During impression making

Countries

India

Contacts

Public ContactDr Rishi Tyagi

University College of Medical Sciences & GTB Hospital Delhi

khatri9804@rediffmail.com9999954120

Outcome results

None listed

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