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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05121584
Other study ID # Pediatric Dentistry
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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