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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Procedure: Placement of an anterior crown restoration as a final restoration

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinder Krown; 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; Placement of an anterior crown restoration as a final restoration
Active Comparator: NuSmile; 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; Placement of an anterior crown restoration as a final restoration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arig Samir Abdelmonem Shawky
• Investigators: Study Director: Fatma Abdelmonem Elhendawy, Professor, Tanta University; Study Director: Fatma Ahmed Elshehaby, Professor, Cairo University; Study Director: Fatma Korany Ismail, Ass.Professor, Cairo University; Principal Investigator: arig samir abdelmonem, bachelor, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): March 21, 2021
• Study Completion (Anticipated): March 21, 2022

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Dental caries; Zirconia crowns in pediatric dentistry; Aesthetic primary teeth restoration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Pediatric Dentistry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No