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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.
Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.
Crown retention
Evaluate whether the crown is present or absent 0= present 1= absent
Time frame: 3, 6, 12 months
Modified gingival index
0= normal 1. mild inflammation 2. moderate inflammation 3. sever inflammation
Time frame: 3, 6, 12 months
Plaque index
Plaque index 0= no plaque 1. film at gingival margin 2. moderate accumulation 3. abundance of plaque
Time frame: 3, 6, 12 months
Occlusion
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
Time frame: 3, 6, 12 months
Surface roughness
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
Time frame: 3, 6, 12 months
Stain resistance
0= no staining 1. minor staining that can be polished 2. noticeable staining that cannot be polished
Time frame: 3, 6, 12 months
Wear of opposing tooth
0= no wear 1. mild wear 2. severe wear
Time frame: 3, 6, 12 months
Color match
0= no color mismatch 1. acceptable crown with color mismatch 2. unacceptable crown with color mismatch
Time frame: 3, 6, 12 months
Anatomic form
0= clinically ideal 1. clinically acceptable (slightly under/over contoured) 2. clinically unacceptable (crown is missing or causing pain)
Time frame: 3, 6, 12 months
Marginal integrity and discoloration
0= clinically ideal 1. clinically acceptable with slight discoloration 2. clinically unacceptable with clear discoloration
Time frame: 3, 6, 12 months
Proximal contact
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
Time frame: 3, 6, 12 months
Recurrent caries
0= clinically ideal with no presence of recurrent caries 1= clinically unacceptable with evidence of recurrent caries
Time frame: 3, 6, 12 months
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