Dental Caries, Restored Decayed Teeth and Post-operative Sensitivity
Conditions
Brief summary
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
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.
Interventions
PROCEDUREUS Public Health Service modified criteria
1, 3 , 6 and 12 months
PROCEDUREThe 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
Sponsors
satish vishwanathaiah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| US Public Health Service (USPHS) modified criteria | 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
| Measure | Time frame | Description |
|---|---|---|
| The parental satisfaction | 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 |
Countries
India
Outcome results
None listed