Resin Polymer vs Stainless Steel Crowns for Tooth Decay

Overseen By Kulsum Iqbal, DMD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Advanced resorption, Irreversible pulpitis, Medically compromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether resin polymer (NuSmile BioFlx) or stainless steel crowns better fix and protect primary molar teeth in children. The crowns restore the tooth's function and prevent further decay or infection. Children aged 3-7 with primary molars that have multiple cavities or defects, and who still have an opposing tooth for chewing, may be suitable candidates for this trial. Participants will receive both types of crowns to compare their effectiveness. As an unphased trial, this study allows participants to contribute to research that could enhance dental care for children.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that resin polymer crowns, such as the NuSmile BioFlx, hold promise for children's dental care. They offer an appealing appearance and a surface texture similar to stainless steel crowns, although more evidence is still being gathered.

Studies have found that stainless steel crowns perform well for children's back teeth, with a high success rate of about 96% over a year. They provide comfort and help maintain dental health.

Both types of crowns are used in dental care, and no major safety issues have been reported for either. While resin polymer crowns are newer, stainless steel crowns have a proven history. Overall, both options appear safe based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the resin polymer crown, NuSmile BioFLX, because it offers a more aesthetic and potentially less invasive alternative to traditional stainless steel crowns for treating tooth decay. Unlike stainless steel, which can be visible and less appealing, the BioFLX crown is tooth-colored, providing a more natural appearance. Additionally, the material used in BioFLX crowns is designed to be biocompatible and may offer improved comfort and fit. These features make it an appealing option for patients seeking both functional and cosmetic dental solutions.

What evidence suggests that this trial's treatments could be effective for tooth decay?

Research has shown that stainless steel crowns effectively fix teeth, with a success rate of about 96% over a year. They are particularly useful for saving badly damaged back teeth and serve as a reliable long-term choice. Resin polymer (NuSmile BioFlx) crowns offer a newer option. Early studies suggest they hold promise for fixing baby molars, with long-term results similar to stainless steel. In this trial, each participant will receive both a BioFLX crown and a stainless steel crown to compare their effectiveness. Both types of crowns restore tooth function and prevent further decay, offering dependable solutions for dental health. ^{1 3 4 6 7}

Who Is on the Research Team?

Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals with primary molar tooth decay who need crowns to restore tooth function and prevent further decay or infection. Specific eligibility criteria are not provided, but typically participants would have no allergies to dental materials and be in good general health.

Inclusion Criteria

My back tooth matches up with another tooth when I bite down.

I have tooth pain or issues but they can be treated.

Consent of parent (legal guardians) and child assent for 7 years

Exclusion Criteria

My child has a serious medical condition.

I have a tooth with irreversible nerve damage.

One of my back teeth is lower than the others.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BioFLX and stainless steel crowns for restoration of primary molar teeth

36 months

Visits at 3, 6, 12, 18, 24, and 36 months

Follow-up

Participants are monitored for clinical and radiographic success, as well as child and parental satisfaction

36 months

Follow-up assessments at 3, 6, 12, 18, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Resin Polymer (NuSmile BioFlx) crown
• Stainless Steel Crown

Trial Overview The study is comparing the effectiveness of two types of crowns for restoring primary molars: one made from a resin polymer (NuSmile BioFlx) and another from stainless steel (3M ESPE). The goal is to see which material better restores function and prevents future caries.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 2 Interventions

Each participant will receive a BioFLX crown and a stainless steel crown.

Resin Polymer (NuSmile BioFlx) crown is already approved in United States for the following indications:

Approved in United States as NuSmile BioFlx for:

• Restoration of primary molar teeth

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

In a study involving 80 posterior crowns, both metal-free polymer crowns (with and without a glass-fiber framework) showed acceptable stability and aesthetic performance over a 12-month period, similar to metal-ceramic crowns.

However, polymer crowns with a glass-fiber framework had significantly higher plaque accumulation and gingival index compared to metal-ceramic crowns, indicating potential challenges in oral hygiene and gum health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance of posterior metal-free polymer crowns with and without fiber reinforcement: one-year results of a randomised clinical trial. Ohlmann, B., Dreyhaupt, J., Schmitter, M., et al.[2006]

Stainless steel crowns (SSCs) are highly durable restorations recommended for primary teeth with extensive decay, large lesions, or after procedures like pulpotomy, showing superior longevity compared to other restorations like amalgams.

SSCs provide full coverage, protecting at-risk tooth surfaces from future decay, making them a cost-effective option, especially for children requiring general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of stainless steel crowns. Seale, NS.[2022]

In a study of 46 healthy children, NuSmile anterior preveneered stainless steel crowns demonstrated a high success rate, with 91% retaining a good to excellent clinical appearance after an average of 12.9 months post-placement.

The crowns showed strong durability, with 88% resisting fracture and 97% maintaining color stability for at least 6 months, making them a reliable option for restoring primary incisors affected by early childhood caries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes for primary anterior teeth treated with preveneered stainless steel crowns. MacLean, JK., Champagne, CE., Waggoner, WF., et al.[2019]

In a study involving 76 children and 264 crowns, it was found that the periodontal health of restored primary molars declined over 18 months, regardless of the crown type used.

The results suggest that traditional stainless steel crowns (SSC) or open-faced SSCs are preferable for restoring primary molars, as they may better maintain oral hygiene and gingival health compared to aesthetic crowns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of oral hygiene and periodontal health around posterior primary molars after their restoration with various crown types. Beldüz Kara, N., Yilmaz, Y.[2016]

In a study of 271 patients with special needs, stainless steel crowns (SSCs) demonstrated a 10-year survival rate of 79.2%, significantly higher than the 63.5% survival rate for amalgam restorations, indicating SSCs are a durable option for restoring permanent teeth.

Radiographic analysis showed that 93% of sites with SSC restorations had less than 2 mm of alveolar bone loss, suggesting that SSCs maintain healthy bone levels and have favorable long-term outcomes in terms of periapical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stainless steel crowns as a restoration for permanent posterior teeth in people with special needs: A retrospective study. Sigal, AV., Sigal, MJ., Titley, KC., et al.[2020]

In a study of 135 primary maxillary incisors restored in 49 children aged 2 to 4 years, composite strip crowns (CSCs) had significantly lower retention rates (79%) compared to preveneered stainless steel crowns (PVSSCs) and zirconia crowns (ZCs), which had retention rates of 100% and 95%, respectively.

CSCs also showed higher rates of material loss and poorer esthetic outcomes, leading to lower parental satisfaction regarding color, while zirconia crowns were rated highest for esthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Comparison of Three Esthetic Full-Coverage Restorations in Primary Maxillary Incisors at 12 Months. Gill, A., Garcia, M., Won An, S., et al.[2020]

RelyX U200, a dual-polymerized self-adhesive resin cement, demonstrated significantly higher retentive strength compared to SmartCem2 and RelyX Luting 2 when used to cement stainless steel crowns, indicating its superior effectiveness in maintaining crown retention.

The study involved 30 extracted teeth and utilized standardized testing methods, confirming that dual-polymerized self-adhesive resin cements provide better retention than resin-modified glass ionomer cement (RMGIC).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro Evaluation of Stainless Steel Crowns cemented with Resin-modified Glass Ionomer and Two New Self-adhesive Resin Cements. Pathak, S., Shashibhushan, KK., Poornima, P., et al.[2022]

Stainless steel crowns (SSCs) placed in primary molars of high caries risk children showed a high overall success rate of 97.2% after 1, 3, and 5 years, indicating their effectiveness as a restorative option.

The study found that poor oral hygiene and high caries prevalence were more significant contributors to gingivitis than the quality of the SSCs themselves, highlighting the importance of maintaining good oral hygiene in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. Schüler, IM., Hiller, M., Roloff, T., et al.[2016]

In a study involving 87 children aged 4-7 years, both stainless steel crowns (SSC) and modified open-sandwich restorations showed high survival rates over 24 months, with 95.0% for SSCs and 92.5% for modified open-sandwich restorations.

The modified open-sandwich technique demonstrated significantly better gingival health compared to SSCs, making it a suitable alternative for extensive restorations, especially when aesthetics are a concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stainless steel crown versus modified open-sandwich restorations for primary molars: a 2-year randomized clinical trial. Atieh, M.[2022]

In a study of 637 anterior crowns placed on primary teeth in children, both NuSmile Signature crowns and conventional stainless steel crowns showed similar retention rates, with failure rates of 9% and 7% respectively.

The findings suggest that both types of crowns are effective options for restoring primary anterior teeth, as there was no statistically significant difference in retention rates between the two crown types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Study of Retention of Stainless Steel Crowns and Pre-veneered Crowns on Primary Anterior Teeth. Lopez-Loverich, AM., Garcia, MM., Donly, KJ.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12563056/

BioFlx Pediatric Crowns: Current Evidence on Clinical ... BioFlx crowns represent an innovative hybrid resin polymer-based alternative for pediatric full-coverage restorations, addressing the clinical ...

2. trial.medpath.com trial.medpath.com/clinical-trial/b5099e19d009aa56/nct06354634-resin-polymer-vs-stainless-steel-crowns-primary-molar-restoration

Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel ... The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06713330

NCT06713330 | Comparing Stainless Steel Crowns with ... The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown ( ...

4. withpower.com withpower.com/trial/phase-dental-decay-3-2024-e2fb0

Resin Polymer vs Stainless Steel Crowns for Tooth Decay Yes, the Resin Polymer (NuSmile BioFlx) crown and Stainless Steel Crown are promising treatments for tooth decay. They show good long-term clinical outcomes, ...

5. smartpatients.com smartpatients.com/trials/NCT06354634

Resin Polymer (NuSmile BioFlx) Compared to Stainless ... The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth.

6. clinicaltrial.be clinicaltrial.be/en/details/432153?per_page=100&only_recruiting=0&only_eligible=0

Resin Polymer (NuSmile BioFlx) Compared to Stainless ... 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, ...

7. researchgate.net researchgate.net/publication/395759958_BioFlx_Pediatric_Crowns_Current_Evidence_on_Clinical_Outcomes_and_Material_Properties

BioFlx Pediatric Crowns: Current Evidence on Clinical ... BioFlx showed intermediate fracture resistance, comparable surface roughness to SSCs but higher than zirconia, and intermediate marginal gaps.