NCT05121584

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

November 14, 2021

Last Update Submit

November 16, 2021

Conditions

Dental Caries in Children

Keywords

Zirconia crowns in pediatric dentistryDental cariesAesthetic primary teeth restoration

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Kinder Krown

EXPERIMENTAL

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

NuSmile

ACTIVE COMPARATOR

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

Interventions

Placement of an anterior crown restoration as a final restorationPROCEDURE

Placement of an anterior crown restoration as a final restoration

Kinder KrownNuSmile

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Fatma Abdelmonem Elhendawy, Professor

    Tanta University

    STUDY DIRECTOR

  • Fatma Ahmed Elshehaby, Professor

    Cairo University

    STUDY DIRECTOR

  • Fatma Korany Ismail, Ass.Professor

    Cairo University

    STUDY DIRECTOR

  • arig samir abdelmonem, bachelor

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
B.D.S

Study Record Dates

First Submitted

November 14, 2021

First Posted

November 16, 2021

Study Start

November 20, 2020

Primary Completion

March 21, 2021

Study Completion

March 21, 2022

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)