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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOFLX crowns ( kids-e-dental) | Experimental | Crowns placed |
|
| Stainless steel crowns (Rainbow crowns) | Active Comparator | Crowns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US Public Health Service modified criteria | Procedure | 1, 3 , 6 and 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1st month, 3rd month, 6th month and 12 th month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1st month and 12th month |
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Inclusion Criteria:
• At least two primary molars (contra-lateral or opposing side) needing full coverage restoration.
Exclusion Criteria:
• Parent not willing to give consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahatma Gandhi dental college and hospital | Jaipur | Rajasthan | 302022 | India |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
|