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The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients.
The main questions it aims to answer are:
Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in terms of crown retention (primary outcome)? Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in modified gingival index, plaque index, occlusion, surface roughness, stain resistance, wear of opposing tooth, color match, anatomic form, marginal integrity and discoloration, proximal contact, and recurrent caries at the crown margins?
Researchers will compare the clinical performance of Bioflx crowns and zirconia crowns to determine if they are similar.
Participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary lower second molar | Experimental | one NuSmile® BioFlx crown will be placed on primary lower second molar. |
|
| Contralateral primary lower second molar | Active Comparator | one zirconia crown will be placed on the contralateral primary lower second molar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFlx crown | Other | NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Crown retention | Evaluate whether the crown is present or absent 0= present 1= absent | 3, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified gingival index | 0= normal
| 3, 6, 12 months |
| Plaque index | Plaque index 0= no plaque
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatimah A Alsuwaiyan, BDS | Contact | 001966508322281 | fatimah.a.alsuwaiyan2022@student.riyadh.edu.sa |
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Data analyst
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| Zirconia crown | Other | Zirconia crown (Group B) will be placed on the contralateral primary lower second molar. |
|
| 3, 6, 12 months |
| Occlusion | 0= clinically ideal with crown in harmony with occlusion
| 3, 6, 12 months |
| Surface roughness | 0= clinically ideal with smooth crown surface
| 3, 6, 12 months |
| Stain resistance | 0= no staining
| 3, 6, 12 months |
| Wear of opposing tooth | 0= no wear
| 3, 6, 12 months |
| Color match | 0= no color mismatch
| 3, 6, 12 months |
| Anatomic form | 0= clinically ideal
| 3, 6, 12 months |
| Marginal integrity and discoloration | 0= clinically ideal
| 3, 6, 12 months |
| Proximal contact | 0= clinically ideal with acceptable resistance to the passage of floss
| 3, 6, 12 months |
| Recurrent caries | 0= clinically ideal with no presence of recurrent caries 1= clinically unacceptable with evidence of recurrent caries | 3, 6, 12 months |