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Clinical Trials/NCT05121584
NCT05121584
Unknown
Not Applicable

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

Arig Samir Abdelmonem Shawky1 site in 1 country25 target enrollmentNovember 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries in Children
Sponsor
Arig Samir Abdelmonem Shawky
Enrollment
25
Locations
1
Primary Endpoint
Crown retention
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 20, 2020
End Date
March 21, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Arig Samir Abdelmonem Shawky
Responsible Party
Sponsor Investigator
Principal Investigator

Arig Samir Abdelmonem Shawky

B.D.S

Tanta University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Crown retention

Time Frame: 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

Time Frame: 12 months

Binary (Yes/No)

Gingival health

Time Frame: 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

Time Frame: 12 months

A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch

Gingival index (Loe and Silness)

Time Frame: 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

Time Frame: 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

Time Frame: 12 months

Binary(Yes/No)

Pathological external/internal root resorption

Time Frame: 12 months

Binary(Present/Absent)

Periapical radiolucency

Time Frame: 12 months

Binary(Present/Absent)

Study Sites (1)

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