Dental CariesNCT06354647
Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves
A study testing Zirconia-based primary anterior crowns with retention grooves and Zirconia-based primary anterior crowns without retention grooves in people with Dental Caries and Tooth Decay, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Tooth Decay
- What is being tested?
- Zirconia-based primary anterior crowns with retention grooves and Zirconia-based primary anterior crowns without retention grooves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 1 Feb 2025
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 2 to 6-year-old children.
- Those having opposed anterior teeth.
- No history of systemic illness or dental developmental anomalies
- Minimal of two surfaces of caries in the upper anterior teeth.
- Patient with Early Childhood Caries.
- Patients treated under General Anesthesia.
- English, Spanish, and Arabic speaking patients
Who cannot join
- Teeth nearing exfoliation.
- The presence of a single surface caries, not involving the proximal surfaces.
- Teeth that have been subjected to trauma.
- Bruxism.
- Special health needs.
- Presence of teeth wear on the opposing teeth, or absence of opposing teeth.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effectiveness of Zirconia-based Crowns With Retention Grooves (Sprig EZ) Versus Without Retention Grooves (NuSmile ZR) for Restoration of Primary Anterior Teeth: A Parallel-arm Randomized Controlled Trial
The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.
Read the detailed description
There are many treatment options available for restoring primary anterior teeth. A clinician's decision to opt for any specific treatment option is based on multiple factors such as the clinician's liking of a specific material or method, esthetic demands by parents, the child's behavior, and moisture and hemorrhage control. Out of many treatment options, preformed zirconia crowns for primary teeth have been available for over a decade. There is insufficient research that compares the success of anterior pediatric zirconia crowns with and without retentive grooves.
- Conditions
- Dental Caries, Tooth Decay
- Being tested
- Zirconia-based primary anterior crowns with retention grooves, Zirconia-based primary anterior crowns without retention grooves
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia-based primary anterior crowns with retention groovesProcedure or surgery
Zirconia-based primary anterior crowns with retention grooves
Zirconia-based primary anterior crowns without retention groovesProcedure or surgery
Zirconia-based primary anterior crowns without retention grooves
| Study group | Role | What they receive |
|---|---|---|
| Zirconia-based primary anterior crowns with retention grooves | Experimental | Participants will receive zirconia-based primary anterior crowns with retention grooves Receives: Procedure: Zirconia-based primary anterior crowns with retention grooves |
| Zirconia-based primary anterior crowns without retention grooves | Experimental | Participants will receive zirconia-based primary anterior crowns without retention grooves Receives: Procedure: Zirconia-based primary anterior crowns without retention grooves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes
The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately:
Contour of crown, Gingival health, Staining of crown, Surface roughness of crown, Opposing tooth, Color match of crown, Marginal fit, Marginal discoloration, Recurrent caries.
Measured: 3, 6, 12, 24 and 36 months
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes
The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes/no) of the findings for the following parameter separately: Widening of periodontal ligament space, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.
Measured: 3, 6, 12, 24 and 36 months
Secondary outcomes (3)
Parental satisfaction
The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.
Measured: 3, 12, 24 and 36 months
Child satisfaction
The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.
Measured: 3, 12, 24 and 36 months
Oral health impact during early childhood
Evaluating Oral health impact during early childhood utilizing the Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire. This is rated on a Likert 5-point scale. (0 = never, 1 = hardly ever, 2 = occasionally, 3 = often, 4 = very often)
Measured: 3, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start7 Jun 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayakumar Jayaraman, MDS, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354647
- Sponsor's protocol ID
- HM20028419
- Status last verified
- Feb 2025
- First submitted
- 3 Apr 2024
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Zirconia-based Crowns With Retention Grooves (Sprig EZ) Versus Without Retention Grooves (NuSmile ZR) for Restoration of Primary Anterior Teeth: A Parallel-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06354647
- Acronym / sponsor ID
- HM20028419
- Conditions
- Dental Caries, Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 9 Apr 2024 (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 purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.
Detailed description
There are many treatment options available for restoring primary anterior teeth. A clinician's decision to opt for any specific treatment option is based on multiple factors such as the clinician's liking of a specific material or method, esthetic demands by parents, the child's behavior, and moisture and hemorrhage control. Out of many treatment options, preformed zirconia crowns for primary teeth have been available for over a decade. There is insufficient research that compares the success of anterior pediatric zirconia crowns with and without retentive grooves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconia-based primary anterior crowns with retention grooves | Experimental | Procedure: Zirconia-based primary anterior crowns with retention groovesParticipants will receive zirconia-based primary anterior crowns with retention grooves |
| Zirconia-based primary anterior crowns without retention grooves | Experimental | Procedure: Zirconia-based primary anterior crowns without retention groovesParticipants will receive zirconia-based primary anterior crowns without retention grooves |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy 2 to 6-year-old children.
- Those having opposed anterior teeth.
- No history of systemic illness or dental developmental anomalies
- Minimal of two surfaces of caries in the upper anterior teeth.
- Patient with Early Childhood Caries.
Key exclusion criteria (6 listed)
- Teeth nearing exfoliation.
- The presence of a single surface caries, not involving the proximal surfaces.
- Teeth that have been subjected to trauma.
- Bruxism.
- Special health needs.
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 |
|---|---|---|
| Zirconia-based primary anterior crowns with retention groovesZirconia-based primary anterior crowns with retention grooves | Procedure or surgery | Zirconia-based primary anterior crowns with retention grooves |
| Zirconia-based primary anterior crowns without retention groovesZirconia-based primary anterior crowns without retention grooves | Procedure or surgery | Zirconia-based primary anterior crowns without retention grooves |
Primary outcome
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes
Time frame: 3, 6, 12, 24 and 36 months
The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately: Contour of crown, Gingival health, Staining of crown, Surface roughness of crown, Opposing tooth, Color match of crown, Marginal fit, Marginal discoloration, Recurrent caries.
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes
Time frame: 3, 6, 12, 24 and 36 months
The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes/no) of the findings for the following parameter separately: Widening of periodontal ligament space, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.
3 secondary outcomes
Parental satisfaction
Time frame: 3, 12, 24 and 36 months
Child satisfaction
Time frame: 3, 12, 24 and 36 months
Oral health impact during early childhood
Time frame: 3, 12, 24 and 36 months
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 26 Feb 2025.
- 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.
Jayakumar Jayaraman, MDS, PhD principal investigator
Virginia Commonwealth 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 Zirconia-based primary anterior crowns with retention grooves and Zirconia-based primary anterior crowns without retention grooves in people with Dental Caries and Tooth Decay, run by Virginia Commonwealth University at 1 site in United States.
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 6 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 26 Feb 2025. 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 United States. 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?
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?
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes (time frame: 3, 6, 12, 24 and 36 months). The study lists 2 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 26 Feb 2025.