Tooth DiseasesNCT03067337
Evaluation Between Zirconia and Stainless Steel Crowns
A study testing Stainless Steel Crown (Group A) and NuSmile Zirconia Crowns (Group B) in people with Tooth Diseases, run by King Abdulaziz University.
Trial summary
Introduction and Research Problem: The aim of this project is to evaluate and compare two full coronal restorations on primary posterior molars over a period of 3, 6 and 12 months in terms of restoration failure, marginal integrity, proximal contact, secondary caries, occlusion and gingival response. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- Stainless Steel Crown (Group A) and NuSmile Zirconia Crowns (Group B)
- 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
- 30 Aug 2015to 30 Dec 2016
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age group of 4-8 years
- Free of any systemic disease
- Cooperative patient
- At least two matched bilateral carious primary molars
- Minimal of two surfaces of caries in the targeted tooth
- Written consent obtained from the parent/guardian
Who cannot join
- Any subject that does not fall under the inclusion criteria were excluded.
About this study
Official title: Clinical Evaluation Between Zirconia Crowns and Stainless Steel Crowns in Primary Molars Teeth
Introduction and Research Problem:
The aim of this project is to evaluate and compare two full coronal restorations on primary posterior molars over a period of 3, 6 and 12 months in terms of restoration failure, marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).
Read more
Materials and Methods:
Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who need restorations will be screened for inclusion criteria till 120 teeth are recruited (60 teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used to ensure equalizing variables for both groups, each patient will have side restored with SSC and the opposite side will be restored with Nu/ZR crowns.
Randomization will be done using Statistical Package for the Social Sciences (SPSS) software version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for each age group separately with a uniform random variable generation. A simple descriptive statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used. Level of significance will be set at (α = 0.05) and level of confidence at (95%).
- Conditions
- Tooth Diseases
- Being tested
- Stainless Steel Crown (Group A), NuSmile Zirconia Crowns (Group B)
- Keywords
- Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stainless Steel Crown (Group A)Device
Also called Stainless Steel Crown
Full coverage restoration for multi-surface carious teeth
NuSmile Zirconia Crowns (Group B)Device
Also called Zirconia crowns
Full coverage restoration for multi-surface carious teeth
| Study group | Role | What they receive |
|---|---|---|
| Stainless Steel Crowns (Group A) | Experimental | Groups that received Stainless Steel Crowns Receives: Device: Stainless Steel Crown (Group A) |
| Zirconia crowns (Group B) | Experimental | Groups that received Zirconia crowns Receives: Device: NuSmile Zirconia Crowns (Group B) |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start30 Aug 2015
- Primary completion30 Aug 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067337
- Sponsor's protocol ID
- Zirconia and SSC
- Status last verified
- Feb 2017
- First submitted
- 22 Jan 2017
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Between Zirconia Crowns and Stainless Steel Crowns in Primary Molars Teeth
- ClinicalTrials.gov ID
- NCT03067337
- Acronym / sponsor ID
- Zirconia and SSC
- Conditions
- Tooth Diseases
- Keywords
- Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 30 Aug 2015 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 1 Mar 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.
Introduction and Research Problem:
The aim of this project is to evaluate and compare two full coronal restorations on primary posterior molars over a period of 3, 6 and 12 months in terms of restoration failure, marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).
Materials and Methods:
Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who need restorations will be screened for inclusion criteria till 120 teeth are recruited (60 teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used to ensure equalizing variables for both groups, each patient will have side restored with SSC and the opposite side will be restored with Nu/ZR crowns.
Randomization will be done using Statistical Package for the Social Sciences (SPSS) software version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for each age group separately with a uniform random variable generation. A simple descriptive statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used. Level of significance will be set at (α = 0.05) and level of confidence at (95%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stainless Steel Crowns (Group A) | Experimental | Device: Stainless Steel Crown (Group A)Groups that received Stainless Steel Crowns |
| Zirconia crowns (Group B) | Experimental | Device: NuSmile Zirconia Crowns (Group B)Groups that received Zirconia crowns |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age group of 4-8 years
- Free of any systemic disease
- Cooperative patient
- At least two matched bilateral carious primary molars
- Minimal of two surfaces of caries in the targeted tooth
Key exclusion criteria (1 listed)
- Any subject that does not fall under the inclusion criteria were excluded.
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 |
|---|---|---|
| Stainless Steel Crown (Group A)Also: Stainless Steel CrownFull coverage restoration for multi-surface carious teeth | Device | Stainless Steel Crowns (Group A) |
| NuSmile Zirconia Crowns (Group B)Also: Zirconia crownsFull coverage restoration for multi-surface carious teeth | Device | Zirconia crowns (Group B) |
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].
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 1 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stainless Steel Crown (Group A) and NuSmile Zirconia Crowns (Group B) in people with Tooth Diseases, 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 6 inclusion and 1 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 1 Mar 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 3 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 1 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.