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A Comparative Clinical Trial to study the Efficacy of Preformed Stainless Steel Crowns & Bioflx Crowns in Primary Molars

Comparative Clinical Evaluation of Preformed Stainless Steel Crowns & Bioflx Crowns in Primary Molars:A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056706
Enrollment
20
Registered
2023-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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: Preformed Pediatric Crowns: Stainless Steel Crown,Bioflx Crown Intervention2: Preformed Pediatric Crown: Bioflx Crowns Control Intervention1: Preformed Pediatric crown: Stainless steel

Sponsors

Manav Rachna Dental College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Teeth with multi-surface caries or pulpally treated teeth. 2.Children who are rated as Frankl positive (score 3) and definitely positive (score 4). 3.Primary molars with more than 2/3rd of root structure present. 4.Children who require atleast 2 full coverage restorations. 5.Primary teeth with sufficient crown structure which allows feasibility of full coronal restoration.

Exclusion criteria

Exclusion criteria: 1.Children with any systemic diseases. 2.Children with special health care needs. 3.Tooth which will be exfoliate within 1 year of crown placement. 4.Children with parafunctional habits. 5.Children with known nickel allergy.

Design outcomes

Primary

MeasureTime frame
To study the clinical success of Bioflx crownTimepoint: 12 month follow-up

Secondary

MeasureTime frame
Which Preformed Pediatric crown is better?Stainless Steel crown or Bioflx crown.Timepoint: 2 years

Countries

India

Contacts

Public ContactDr Sakshi Shah

Manav Rachna Dental College

tanunangia.sds@mrei.ac.in7990603771

Outcome results

None listed

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