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

Not Applicable

• Conditions: Dental Caries in Children
• Interventions: Procedure: Placement of an anterior crown restoration as a final restoration

• Registration Number: NCT05121584
• Lead Sponsor: Arig Samir Abdelmonem Shawky

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2021-03-21
• Status Verified: 2021-11
• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-16
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-18
• Study Completion: 2022-03-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kinder Krown	Placement of an anterior crown restoration as a final restoration	Anterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration
NuSmile	Placement of an anterior crown restoration as a final restoration	Anterior primary teeth which restored by a NuSmile zirconia crown as a final restoration

Primary Outcome Measures

Name	Time	Method
Crown retention	12 months	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
Opposing tooth wear	12 months	Binary (Yes/No)
Gingival health	12 months	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
Immediate color match	12 months	A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch
Gingival index (Loe and Silness)	12 months	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
Crown margins	12 months	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
Child/parent satisfaction	12 months	Binary(Yes/No)
Pathological external/internal root resorption	12 months	Binary(Present/Absent)
Periapical radiolucency	12 months	Binary(Present/Absent)

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt