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Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars

NCT07465211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-11

No results posted yet for this study

Summary

Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. This research compares the clinical effectiveness of Bioflx crowns (Kids-e-dental)TM to the "gold standard" Stainless Steel crowns (Rainbow crowns)TM

Conditions

  • Dental Caries
  • Restored Decayed Teeth and Post-operative Sensitivity

Interventions

PROCEDURE

US Public Health Service modified criteria

1, 3 , 6 and 12 months

PROCEDURE

The parental satisfaction

rated as (1) strongly disagree, (2) disagree, (3) not sure, (4) agree, and (5) strongly agree for five variables - color, size, shape, fit and overall satisfaction. The score 1 and 2 were combined as satisfied, Score 3 indicated neutral response, Score 4 and 5 were combined as dissatisfied

Sponsors & Collaborators

  • satish vishwanathaiah

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-22
Primary Completion
2025-09-25
Completion
2025-09-27

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465211 on ClinicalTrials.gov