Dental Caries in ChildrenNCT05121584
Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth
A study testing Placement of an anterior crown restoration as a final restoration in people with Dental Caries in Children, run by Arig Samir Abdelmonem Shawky at 1 site in Egypt.
Trial summary
Evaluation of two different types of zirconia crowns ( Kinder Krown , Nusmile crown) used in carious primary anterior teeth Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Placement of an anterior crown restoration as a final restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of two different types of zirconia crowns ( Kinder Krown , Nusmile crown) used in carious primary anterior teeth
Read the 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
- Conditions
- Dental Caries in Children
- Being tested
- Placement of an anterior crown restoration as a final restoration
- Keywords
- Zirconia crowns in pediatric dentistry, Dental caries, Aesthetic primary teeth restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of an anterior crown restoration as a final restorationProcedure or surgery
Placement of an anterior crown restoration as a final restoration
| Study group | Role | What they receive |
|---|---|---|
| Kinder Krown | Experimental | Anterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration Receives: 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 Receives: Procedure: Placement of an anterior crown restoration as a final restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Opposing tooth wear
Binary (Yes/No)
Measured: 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
Measured: 12 months
Immediate color match
A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch
Measured: 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
Measured: 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
Measured: 12 months
Child/parent satisfaction
Binary(Yes/No)
Measured: 12 months
Pathological external/internal root resorption
Binary(Present/Absent)
Measured: 12 months
Periapical radiolucency
Binary(Present/Absent)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Nov 2020
- Primary completion21 Mar 2021
- Study completion21 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arig Samir Abdelmonem Shawky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arig Samir Abdelmonem Shawky, Tanta University
- Investigators
- Fatma Abdelmonem Elhendawy, Professor, Study director, Tanta UniversityFatma Ahmed Elshehaby, Professor, Study director, Cairo UniversityFatma Korany Ismail, Ass.Professor, Study director, Cairo Universityarig samir abdelmonem, bachelor, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121584
- Sponsor's protocol ID
- Pediatric Dentistry
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth
- ClinicalTrials.gov ID
- NCT05121584
- Acronym / sponsor ID
- Pediatric Dentistry
- Conditions
- Dental Caries in Children
- Keywords
- Zirconia crowns in pediatric dentistry, Dental caries, Aesthetic primary teeth restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Arig Samir Abdelmonem ShawkyUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Mar 2022 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinder Krown | Experimental | Procedure: Placement of an anterior crown restoration as a final restorationAnterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration |
| NuSmile | Active comparator | Procedure: Placement of an anterior crown restoration as a final restorationAnterior primary teeth which restored by a NuSmile zirconia crown as a final restoration |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of an anterior crown restoration as a final restorationPlacement of an anterior crown restoration as a final restoration | Procedure or surgery | Kinder Krown, NuSmile |
Primary outcome
Crown retention
Time frame: 12 months
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
Time frame: 12 months
Binary (Yes/No)
Gingival health
Time frame: 12 months
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
Time frame: 12 months
A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch
Gingival index (Loe and Silness)
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
Binary(Yes/No)
Pathological external/internal root resorption
Time frame: 12 months
Binary(Present/Absent)
Periapical radiolucency
Time frame: 12 months
Binary(Present/Absent)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Abdelmonem Elhendawy, Professor study director
Tanta University
Fatma Ahmed Elshehaby, Professor study director
Cairo University
Fatma Korany Ismail, Ass.Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of an anterior crown restoration as a final restoration in people with Dental Caries in Children, run by Arig Samir Abdelmonem Shawky at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crown retention (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.