Clincal Evaluation of BioFlx Vs. Zirconia Crowns
Conditions
Brief summary
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: * Participants will be asked to attend two appointments. During the first visit, a BioFlx crown will be placed on the primary lower second molar, and during the second visit, a zirconia crown will be placed on the contralateral primary lower second molar. * Participants will be recalled and evaluated after 3, 6, and 12 months.
Interventions
OTHERBioFlx crown
NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.
OTHERZirconia crown
Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.
Sponsors
Riyadh Elm University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Data analyst
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 5-9 years old. * American Society of Anesthesiologists Classification I or II status. * Cooperative child. * Obtained informed consent. * Two primary lower second molars requiring full coverage restorations. * Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth. * Primary lower second molars that can be adequately isolated. * Pulptomized primary lower second molars. * Primary lower second molars with multi-surface caries.
Exclusion criteria
* American Society of Anesthesiologists Classification higher or equal to three statuses. * Informed consent is not obtained. * Allergy to local anesthesia. * Non-restorable primary lower second molars.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crown retention | 3, 6, 12 months | Evaluate whether the crown is present or absent 0= present 1= absent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified gingival index | 3, 6, 12 months | 0= normal 1. mild inflammation 2. moderate inflammation 3. sever inflammation |
| Plaque index | 3, 6, 12 months | Plaque index 0= no plaque 1. film at gingival margin 2. moderate accumulation 3. abundance of plaque |
| Occlusion | 3, 6, 12 months | 0= clinically ideal with crown in harmony with occlusion 1. clinically acceptable with crown occluding slightly high or low 2. clinically unacceptable and crown needs to be replaced |
| Surface roughness | 3, 6, 12 months | 0= clinically ideal with smooth crown surface 1. clinically acceptable with slight rough surface 2. clinically unacceptable with crown fracture or pitting that require replacement |
| Stain resistance | 3, 6, 12 months | 0= no staining 1. minor staining that can be polished 2. noticeable staining that cannot be polished |
| Wear of opposing tooth | 3, 6, 12 months | 0= no wear 1. mild wear 2. severe wear |
| Anatomic form | 3, 6, 12 months | 0= clinically ideal 1. clinically acceptable (slightly under/over contoured) 2. clinically unacceptable (crown is missing or causing pain) |
| Marginal integrity and discoloration | 3, 6, 12 months | 0= clinically ideal 1. clinically acceptable with slight discoloration 2. clinically unacceptable with clear discoloration |
| Proximal contact | 3, 6, 12 months | 0= clinically ideal with acceptable resistance to the passage of floss 1. clinically acceptable with tight or loose passage of floss 2. clinically unacceptable with no contact with adjacent tooth |
| Recurrent caries | 3, 6, 12 months | 0= clinically ideal with no presence of recurrent caries 1= clinically unacceptable with evidence of recurrent caries |
| Color match | 3, 6, 12 months | 0= no color mismatch 1. acceptable crown with color mismatch 2. unacceptable crown with color mismatch |
Contacts
Primary ContactFatimah A Alsuwaiyan, BDS
Outcome results
None listed