NCT07465211

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

Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars - A Randomised Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: satish vishwanathaiah · Other Government
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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

Detailed description

A split mouth trial was conducted among 36 children of age 6-8 years, in which Bioflx crowns (Kids-e-dental)TM and Stainless Steel crowns (Rainbow crowns)TM are placed in each primary molar in bilateral or contra-lateral sides. The clinical effectiveness is evaluated using US Public Health Service modified criteria at baseline and after 1,3,6 and 12 months. The parental satisfaction of restoration is recorded using a 5-point Likert scale at baseline and 12 months. Descriptive statistics and intra-group comparison were analyzed using Chi-square test, while intergroup comparison was analyzed using Mann-Whitney test.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-22
• Primary completion: 2025-09-25
• Completion: 2025-09-27
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: India