Dental CariesNCT06354634
Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth
A study testing Resin polymer (NuSmile Bioflx) crown and Stainless steel crown 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 molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Dental Caries, Tooth Decay
- What is being tested?
- Resin polymer (NuSmile Bioflx) crown and Stainless steel crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: Children age group 3-7 yrs old
- Primary molars affected with caries or hypoplastic defect.
- Occlusion: Primary molar must have antagonist tooth.
- Consent of parent (legal guardians) and child assent for 7 years.
- Multi-surface dental caries observed in more than one tooth, in either side of the same arch (maxilla or mandible) or opposite arch (maxilla or mandible)
- Status: Asymptomatic or symptomatic teeth with signs of reversible pulpitis
Who cannot join
- Teeth with advanced stages of resorption (more than 2/3rd)
- Teeth exhibiting irreversible pulpitis.
- Teeth for which pulpotomy is done.
- Molar in infraocclusion
- Medically compromised children (ASA 3 or 4)
- History of grinding or pathological attrition
- Adverse gingival or periodontal conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Clinical and Radiographic Success of Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel (3M ESPE) Crowns for Restoration of Primary Molar Teeth: a Split Mouth 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 molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.
Read the detailed description
There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.
- Conditions
- Dental Caries, Tooth Decay
- Being tested
- Resin polymer (NuSmile Bioflx) crown, Stainless steel 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.
Resin polymer (NuSmile Bioflx) crownOther
Resin polymer (NuSmile Bioflx)crown
Stainless steel crownOther
Stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Each participant will receive a BioFLX crown and a stainless steel crown. Receives: Other: Resin polymer (NuSmile Bioflx) crown; Other: Stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments
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, 18, 24 and 36 months
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments
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, furcation radiolucency, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.
Measured: 3, 6, 12, 18, 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
ECOHIS (Early Childhood Oral Health Impact Scale) survey
The questionnaire is a Likert scale of 1-5. 1 equals never. 5 equals very often. The lower the score, the better.
Measured: Pre-operative, 6, 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
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will receive both interventions.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354634
- Sponsor's protocol ID
- HM20028439
- Status last verified
- Feb 2025
- First submitted
- 27 Mar 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
- Clinical and Radiographic Success of Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel (3M ESPE) Crowns for Restoration of Primary Molar Teeth: a Split Mouth Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06354634
- Acronym / sponsor ID
- HM20028439
- Conditions
- Dental Caries, Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 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 molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.
Detailed description
There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will receive both interventions.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Resin polymer (NuSmile Bioflx) crown, Other: Stainless steel crownEach participant will receive a BioFLX crown and a stainless steel crown. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: Children age group 3-7 yrs old
- Primary molars affected with caries or hypoplastic defect.
- Occlusion: Primary molar must have antagonist tooth.
- Consent of parent (legal guardians) and child assent for 7 years.
- Multi-surface dental caries observed in more than one tooth, in either side of the same arch (maxilla or mandible) or opposite arch (maxilla or mandible)
Key exclusion criteria (7 listed)
- Teeth with advanced stages of resorption (more than 2/3rd)
- Teeth exhibiting irreversible pulpitis.
- Teeth for which pulpotomy is done.
- Molar in infraocclusion
- Medically compromised children (ASA 3 or 4)
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 |
|---|---|---|
| Resin polymer (NuSmile Bioflx) crownResin polymer (NuSmile Bioflx)crown | Other | All participants |
| Stainless steel crownStainless steel crown | Other | All participants |
Primary outcome
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments
Time frame: 3, 6, 12, 18, 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.
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments
Time frame: 3, 6, 12, 18, 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, furcation radiolucency, 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
ECOHIS (Early Childhood Oral Health Impact Scale) survey
Time frame: Pre-operative, 6, 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, BDS, MDS, FDSRCS, MS, 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 Resin polymer (NuSmile Bioflx) crown and Stainless steel crown 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 6 inclusion and 7 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?
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments (time frame: 3, 6, 12, 18, 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.