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Completed

NCT Number: NCT07465211

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

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

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Key information

Conditions

Dental Caries Restored Decayed Teeth and Post-operative Sensitivity Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahatma Gandhi dental college and hospital

Jaipur, Rajasthan, 302022, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

US Public Health Service modified criteria

Procedure

1, 3 , 6 and 12 months

The parental satisfaction

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

satish vishwanathaiah

Other Gov

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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