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.
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bashaer S. Abdulhadi, King Abdulaziz University
- Investigators
- Bashaer S Abdulhadi, MSc, Principal investigator, King Abdulaziz University
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
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.
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.
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).
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.