An interventional study of US Public Health Service modified criteria and The parental satisfaction in Dental Caries and Restored Decayed Teeth and Post-operative Sensitivity, sponsored by satish vishwanathaiah. Completed at 1 site in India. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by satish vishwanathaiah · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
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At least two primary molars (contra-lateral or opposing side) needing full coverage restoration.
Exclusion Criteria:
Parent not willing to give consent.
Crowns placed
Procedure: US Public Health Service modified criteria · Procedure: The parental satisfaction
Crowns
Procedure: US Public Health Service modified criteria · Procedure: The parental satisfaction
1, 3 , 6 and 12 months
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
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
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
Plan to share: No
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