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

satish vishwanathaiah36 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dental Caries Restored Decayed Teeth and Post-operative Sensitivity

Interventions

US Public Health Service modified criteriaPROCEDURE

1, 3 , 6 and 12 months

The parental satisfactionPROCEDURE

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

Eligibility

Sex: ALLMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Mahatma Gandhi dental college and hospital

Jaipur, Rajasthan, India

Outcomes

Primary Outcomes

US Public Health Service (USPHS) modified criteria

The following variableswere assessed; retention, color match, marginal discoloration and adaptation, secondary caries, wear and post-operative sensitivity

Time frame: 1st month, 3rd month, 6th month and 12 th month

Secondary Outcomes

The parental satisfaction

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

Time frame: 1st month and 12th month

Data from ClinicalTrials.gov

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