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

March 6, 2026 updated by: satish vishwanathaiah

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India, 302022
        • Mahatma Gandhi dental college and hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • At least two primary molars (contra-lateral or opposing side) needing full coverage restoration.

    • Consent of patient/legal guardian of the child
    • Cooperative behaviour based on Frankel behaviour rating 3 or 4 (positive or definitely positive)

Exclusion Criteria:

  • • Parent not willing to give consent.

    • Child with special health care needs
    • Uncooperative child based on Frankel rating1or 2 (definitely negative or negative)
    • History of Ni-Cr allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIOFLX crowns ( kids-e-dental)
Crowns placed
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
Active Comparator: Stainless steel crowns (Rainbow crowns)
Crowns
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
US Public Health Service (USPHS) modified criteria
Time Frame: 1st month, 3rd month, 6th month and 12 th month
The following variableswere assessed; retention, color match, marginal discoloration and adaptation, secondary caries, wear and post-operative sensitivity
1st month, 3rd month, 6th month and 12 th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The parental satisfaction
Time Frame: 1st month and 12th month
5-point Likert scale developed by Alkhouli et al 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
1st month and 12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

satish vishwanathaiah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2025

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

September 27, 2025

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mahatma gandhi dental college

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on US Public Health Service modified criteria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe