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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05121584
• Other study ID #: Pediatric Dentistry
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: March 21, 2022

Study information

• Verified date: November 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Procedure:
• Placement of an anterior crown restoration as a final restoration
Placement of an anterior crown restoration as a final restoration

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Arig Samir Abdelmonem Shawky

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Opposing tooth wear	Binary (Yes/No)	12 months
Primary	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
Primary	Immediate color match	A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch	12 months
Primary	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
Primary	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
Primary	Child/parent satisfaction	Binary(Yes/No)	12 months
Primary	Pathological external/internal root resorption	Binary(Present/Absent)	12 months
Primary	Periapical radiolucency	Binary(Present/Absent)	12 months