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

Primary Purpose

Dental Caries in Children

Status

Active

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Placement of an anterior crown restoration as a final restoration

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring Zirconia crowns in pediatric dentistry, Dental caries, Aesthetic primary teeth restoration

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinder Krown

NuSmile

Arm Description

Anterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration

Anterior primary teeth which restored by a NuSmile zirconia crown as a final restoration

Outcomes

Primary Outcome Measures

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

Opposing tooth wear

Binary (Yes/No)

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

Immediate color match

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

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

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

Child/parent satisfaction

Binary(Yes/No)

Pathological external/internal root resorption

Binary(Present/Absent)

Periapical radiolucency

Binary(Present/Absent)

Secondary Outcome Measures

Full Information

NCT ID

NCT05121584

First Posted

November 14, 2021

Last Updated

November 16, 2021

Sponsor

Arig Samir Abdelmonem Shawky

1. Study Identification

Unique Protocol Identification Number

NCT05121584

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 20, 2020 (Actual)

Primary Completion Date

March 21, 2021 (Actual)

Study Completion Date

March 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Arig Samir Abdelmonem Shawky

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries in Children

Keywords

Zirconia crowns in pediatric dentistry, Dental caries, Aesthetic primary teeth restoration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kinder Krown

Arm Type

Experimental

Arm Description

Anterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration

Arm Title

NuSmile

Arm Type

Active Comparator

Arm Description

Anterior primary teeth which restored by a NuSmile zirconia crown as a final restoration

Intervention Type

Procedure

Intervention Name(s)

Placement of an anterior crown restoration as a final restoration

Intervention Description

Placement of an anterior crown restoration as a final restoration

Primary Outcome Measure Information:

Title

Crown retention

Description

Time Frame

12 months

Title

Opposing tooth wear

Description

Binary (Yes/No)

Time Frame

12 months

Title

Gingival health

Description

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

Time Frame

12 months

Title

Immediate color match

Description

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

Time Frame

12 months

Title

Gingival index (Loe and Silness)

Description

Time Frame

12 months

Title

Crown margins

Description

Time Frame

12 months

Title

Child/parent satisfaction

Description

Binary(Yes/No)

Time Frame

12 months

Title

Pathological external/internal root resorption

Description

Binary(Present/Absent)

Time Frame

12 months

Title

Periapical radiolucency

Description

Binary(Present/Absent)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fatma Abdelmonem Elhendawy, Professor

Organizational Affiliation

Tanta University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fatma Ahmed Elshehaby, Professor

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fatma Korany Ismail, Ass.Professor

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

arig samir abdelmonem, bachelor

Organizational Affiliation

Tanta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tanta University

City

Tanta

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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