Dental CariesNCT03184012

Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

A study testing NuSmile Zirconia crowns by NuSmile company and Composite resin strip crowns by 3M company in people with Dental Caries, run by King Abdulaziz University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The hypothesis to be investigated is that no difference will be found upon comparing resin composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in restoring anterior primary teeth. Read more about this study

Who is it for?: Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: NuSmile Zirconia crowns by NuSmile company and Composite resin strip crowns by 3M company
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: 1 Nov 2015to 30 Jan 2017
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 4 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy Children with no history of any systemic illness or any developmental disease of the teeth and jaws that would have affected dietary patterns, caries, susceptibility or the selection of restorative materials to the best of current knowledge.
Minimal of two surfaces of caries in the targeted tooth.
Patient with Early Childhood Caries as defined by American Academy of Pediatric Dentistry (AAPD), 2016.
Cooperative patient who had behavioral rating "positive" or "definitely positive" followed the Frankl behavior classification scale. (Frankl et al. 1962)
Opposing teeth present.
Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomfort, risks, and benefits.
No patient was excluded on the basis of gender, race, social or economic background.

Who cannot join

Teeth with proximity to exfoliation and resorption of the root passed its half.
Patients with allergy or hypersensitivity to nickel in case of posterior group teeth.
Presence of single surface caries not involving the proximal surfaces.
Teeth that has been subjected to trauma.
Anxious, uncooperative patients who need to be treated under general anesthesia.
Children who suffer from bruxism.
Children with special needs.
Presence of tooth wear on the opposing teeth (in case of anterior teeth), or absence of opposing.

About this study

Official title: Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns

Read the detailed description

The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary anterior crowns, compared with anterior resin composite strip crowns in the restoration of 120 teeth (primary incisors and lateral anterior teeth in the deciduous dentition of child patients).

Conditions: Dental Caries
Being tested: NuSmile Zirconia crowns by NuSmile company, Composite resin strip crowns by 3M company
Keywords: caries, full coverage, strip crown, Zirconia crown, primary anterior teeth, crown
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NuSmile Zirconia crowns by NuSmile companyDevice
anterior carious teeth restored with Zirconia crowns
Composite resin strip crowns by 3M companyDevice
anterior carious teeth restored with Strip crowns

Study groups in NCT03184012
Study group	Role	What they receive
NuSmile Zirconia crowns	Experimental	NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth. Receives: Device: NuSmile Zirconia crowns by NuSmile company
Composite resin strip crowns	Experimental	Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth. Receives: Device: Composite resin strip crowns by 3M company

What is being measured

The primary outcome is the main question the study is designed to answer.

Gingival Health
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Measured: 3-month follow-up
Plaque index
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe,1967].
Measured: 3-month follow-up
Restoration failure
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Measured: 3-month follow-up
Tooth wear of opposing dentition
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)
Measured: 3-month follow-up
Gingival Health
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Measured: 6-month follow-up
Plaque index
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Measured: 6-month follow-up
Restoration failure
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Measured: 6-month follow-up
Tooth wear of opposing dentition
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)
Measured: 6-month follow-up
Gingival Health
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Measured: 12-month follow-up
Plaque index
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Measured: 12-month follow-up
Restoration failure
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Measured: 12-month follow-up
Tooth wear of opposing dentition
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)
Measured: 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201530 Jan 2017

First posted12 Jun 2017
Study start1 Nov 2015
Primary completion1 Nov 2016
Study completion30 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental CariesStudies 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
Model description: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03184012
Sponsor's protocol ID: King Abdulaziz University
Status last verified: Jun 2017
First submitted: 2 Jun 2017
Last updated: 12 Jun 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Alaki SM, Abdulhadi BS, AbdElBaki MA, Alamoudi NM. Comparing zirconia to anterior strip crowns in primary anterior teeth in children: a randomized clinical trial. BMC Oral Health. 2020 Nov 10;20(1):313. doi: 10.1186/s12903-020-01305-1.
PubMed 33167954

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns
ClinicalTrials.gov ID: NCT03184012
Acronym / sponsor ID: King Abdulaziz University
Conditions: Dental Caries
Keywords: caries, full coverage, strip crown, Zirconia crown, primary anterior teeth, crown
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: King Abdulaziz UniversityUniversity, hospital or other
Study start: 1 Nov 2015 (actual)
Primary completion: 1 Nov 2016 (actual)
Study completion: 30 Jan 2017 (actual)
First posted: 12 Jun 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns

Arm	Type	Receives
NuSmile Zirconia crowns	Experimental	Device: NuSmile Zirconia crowns by NuSmile companyNuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.
Composite resin strip crowns	Experimental	Device: Composite resin strip crowns by 3M companyComposite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.

Who may qualify

Ages: 4 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Healthy Children with no history of any systemic illness or any developmental disease of the teeth and jaws that would have affected dietary patterns, caries, susceptibility or the selection of restorative materials to the best of current knowledge.
Minimal of two surfaces of caries in the targeted tooth.
Patient with Early Childhood Caries as defined by American Academy of Pediatric Dentistry (AAPD), 2016.
Cooperative patient who had behavioral rating "positive" or "definitely positive" followed the Frankl behavior classification scale. (Frankl et al. 1962)
Opposing teeth present.

Key exclusion criteria (8 listed)

Teeth with proximity to exfoliation and resorption of the root passed its half.
Patients with allergy or hypersensitivity to nickel in case of posterior group teeth.
Presence of single surface caries not involving the proximal surfaces.
Teeth that has been subjected to trauma.
Anxious, uncooperative patients who need to be treated under general anesthesia.

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
NuSmile Zirconia crowns by NuSmile companyanterior carious teeth restored with Zirconia crowns	Device	NuSmile Zirconia crowns
Composite resin strip crowns by 3M companyanterior carious teeth restored with Strip crowns	Device	Composite resin strip crowns

Primary outcome

Gingival Health
Time frame: 3-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Plaque index
Time frame: 3-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe,1967].
Restoration failure
Time frame: 3-month follow-up
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Tooth wear of opposing dentition
Time frame: 3-month follow-up
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)
Gingival Health
Time frame: 6-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Plaque index
Time frame: 6-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Restoration failure
Time frame: 6-month follow-up
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Tooth wear of opposing dentition
Time frame: 6-month follow-up
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)
Gingival Health
Time frame: 12-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Plaque index
Time frame: 12-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Restoration failure
Time frame: 12-month follow-up
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Tooth wear of opposing dentition
Time frame: 12-month follow-up
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
Derived from this study: PubMed 33167954Alaki SM, Abdulhadi BS, AbdElBaki MA, Alamoudi NM. Comparing zirconia to anterior strip crowns in primary anterior teeth in children: a randomized clinical trial. BMC Oral Health. 2020 Nov 10;20(1):313. doi: 10.1186/s12903-020-01305-1.
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.

Bashaer S Abdulhadi, MSc principal investigator

King Abdulaziz University

Questions about this trial

What is this clinical trial studying?

A study testing NuSmile Zirconia crowns by NuSmile company and Composite resin strip crowns by 3M company in people with Dental Caries, run by King Abdulaziz University.

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 7 inclusion and 8 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: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Gingival Health (time frame: 3-month follow-up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03184012, which also lists 1 linked publication.

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 12 Jun 2017.