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Advancements in pediatric posterior crowns.

Evaluation of preformed BioFlx crowns, Zirconia crowns and Stainless-steel crowns on primary molars: A 12-month randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064787
Enrollment
45
Registered
2024-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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: Posterior crown: Stainless-steel crown, Zirconia crown, BioFlx crown for 1 year Control Intervention1: Modified USPHS criteria: Total time required for preparation, fitting and cementat
plaque accumulation
retention of crown
tooth wear in opposing teeth
radiographic findings at baseline, 3months, 6 months and 12 months interval.

Sponsors

Dr. Nidhi S Shetty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children of 3-9 years of age Children healthy and free of any systemic diseases Primary teeth requiring full coronal restorations following pulpotomy/pulpectomy Primary teeth with at least 2/3rd of the root length remaining Children who are co-operative (Frankl rating of 3 and 4) Children for whom consent was obtained from parents

Exclusion criteria

Exclusion criteria: Teeth with tooth resorption. Infection/ inflammation involving the furcation area. Teeth with inadequate crown structure. Children with any underlying diseases. Children who are non-co-operative (Frankl rating of 1 and 2) Parents who are not willing to participate.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the clinical outcome of preformed BioFlx crowns, Zirconia crowns and Stainless-Steel crowns over a period of 0, 3, 6 and 12 months when used to restore primary molars.Timepoint: The crown will be clinically assessed for: the total time required for preparation, fitting and cementation; plaque accumulation; retention of the crown; tooth wear in opposing teeth; and radiographic findings at baseline, 3 months, 6 months and 12 months.

Secondary

MeasureTime frame
To assess the child and parental satisfaction of preformed BioFlx crowns, Zirconia crowns and Stainless-Steel crowns.Timepoint: A questionnaire will be asked to fill at the end of 12 months

Countries

India

Contacts

Public ContactDr Nidhi S Shetty

RajaRajeswari Dental College and Hospital

amrutha.b87@gmail.com8105700221

Outcome results

None listed

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