Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth

Study Overview
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Brief Summary
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Evaluation of two different types of zirconia crowns ( Kinder Krown , Nusmile crown) used in carious primary anterior teeth

Detailed Description
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Assess the clinical and radiographic evaluation of Kinder Krowns and Nusmile crowns in restoring carious primary canines And compare between the two crowns used

Official Title
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Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Procedure: Placement of an anterior crown restoration as a final restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age ranging from 7 to 10 years Deep carious primary upper canines The tooth need pulpal treatment The tooth need a crown restoration The tooth not submerged The tooth is not mobile Exclusion Criteria: Children with bruxism or deep bite Children with especial need Presence of pathological root resorption in preoperative x-ray Presence of tooth wear (abrasion/attrition) on the opposing teeth

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinder Krown<br>Anterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration | Procedure: Placement of an anterior crown restoration as a final restoration<br>* Placement of an anterior crown restoration as a final restoration<br>|
| Active Comparator: NuSmile<br>Anterior primary teeth which restored by a NuSmile zirconia crown as a final restoration | Procedure: Placement of an anterior crown restoration as a final restoration<br>* Placement of an anterior crown restoration as a final restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crown retention | Change in the following clinical assessment measure between baseline and 12 months using the scale below A=Intact B=Chipped/small but noticeable areas of loss of material C=Large loss of material D=Complete loss of crown | 12 months | 
| Opposing tooth wear | Binary (Yes/No) | 12 months | 
| Gingival health | Change in the following clinical assessment measure between baseline and 12 months using the scale below A=No inflammation B=Mild inflammation C=Moderate inflammation D=Marked inflammation | 12 months | 
| Immediate color match | A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch | 12 months | 
| Gingival index (Loe and Silness) | Change in the following clinical assessment measure between baseline and 12 months using the scale below 0=Normal gingiva(natural colour pink gingiva no inflammation) 1=Mild inflammation(slight changes in colour,slight edema,no bleeding on probing) 2=Moderate inflammation(redness, edema and glazing, bleeding upon probing 3=Severe inflammation(marked redness and edema/ulceration/tendency to bleed spontaneously | 12 months | 
| Crown margins | Change in the following clinical assessment measure between baseline and 12 months using the scale below A=Continuous with the contour of the crown, nice adaptation B=Slight overhang or under contour present C=Large defects noted D=Restoration missing | 12 months | 
| Child/parent satisfaction | Binary(Yes/No) | 12 months | 
| Pathological external/internal root resorption | Binary(Present/Absent) | 12 months | 
| Periapical radiolucency | Binary(Present/Absent) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Aesthetic primary teeth restoration, Zirconia crowns in pediatric dentistry