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Clinical Comparison of two different types of crowns in primary teeth.

Comparative evaluation of clinical success of stainless steel and Kids-e- Bioflex crowns in primary teeth – A split mouth prospective randomized clinical study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041134
Enrollment
100
Registered
2022-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Kids-e-Bioflex Crowns: This is an in-vivo study that will be conducted to evaluate and compare clinical success of Stainless steel crown and Kids-e- Bioflex crown. The patients aged 4-1
an SCC will be tried and adjusted to fit the tooth. According to the manufacturing instructions, tooth preparation will be done and occlusion will be assessed. Prepared tooth should be free from blood

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parents willing to give consent. Primary teeth indicated for full coverage restoration. Frankel’s positive and definitely positive patients Children aged between 4 to 10 years. No significant medical history. Patients willing to return for follow-up examinations and evaluation. Medically free patients or with controlled systemic disease ASA I or II. No active periodontal diseases.

Exclusion criteria

Exclusion criteria: Any subject that does not fall under the inclusion criteria were excluded. Parents not willing to give consent. Children below the age of 4 and above the age of 10. Children with special needs. Inadequate root length. Presence of malocclusion like cross bite, crowding, scissor bite etc. Child allergic to local anesthesia, chromium, or nickel

Design outcomes

Primary

MeasureTime frame
The primary outcome is the success of the treatment. Success will be defined by the absence of major failure fracture, wear, color change Duration, occlusion, gingival margin extension and parent acceptance will be clinically evaluated at baseline and at last appointment Timepoint: one year

Secondary

MeasureTime frame
The secondary outcomes are parental and child satisfaction (size, form, and function), retention and fracture of the crown. The wear of the antagonist tooth will be recorded. gingival condition, the wear of the antagonist teeth, as well as both parental and child satisfaction. Timepoint: one year

Countries

India

Contacts

Public ContactDr Amol Patil

M A Rangoonwala College of Dental Sciences and Research Institute Pune

amolpatil2526@gmail.com9561042279

Outcome results

None listed

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