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

28 Participants Needed

Trial Summary

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.

What data supports the idea that Resin Polymer vs Stainless Steel Crowns for Tooth Decay is an effective treatment?

The available research shows that stainless steel crowns (SSCs) are highly durable and effective for treating tooth decay, especially in children with extensive decay or large lesions. They are known for their longevity and ability to protect teeth from future decay. SSCs are also cost-effective due to their durability. While the research does not directly compare resin polymer crowns to SSCs for tooth decay, it highlights the effectiveness of SSCs in protecting teeth and maintaining oral health. ^{1 2 3 4 5}

What safety data exists for resin polymer and stainless steel crowns for tooth decay?

The safety data for resin polymer and stainless steel crowns includes several studies. One study compared the clinical outcomes of NuSmile preveneered stainless steel crowns, composite strip crowns, and zirconia crowns, finding that NuSmile crowns had better retention and durability. Another study focused on the use of stainless steel crowns in people with special needs, comparing them to amalgam and composite resin restorations. Additionally, a retrospective review explored the retention of NuSmile pre-veneered and 3M ESPE stainless steel crowns on primary anterior teeth. These studies provide insights into the clinical performance and safety of these crowns. ^{3 6 7 8 9}

Is the treatment Resin Polymer (NuSmile BioFlx) crown, Stainless Steel Crown a promising treatment 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, high retention rates, and parental satisfaction, especially in children with high caries risk. ^{2 3 6 7 10}

What is the purpose of this 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.

Research Team

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

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of oral hygiene and periodontal health around posterior primary molars after their restoration with various crown types. [2016]

2. India 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes for primary anterior teeth treated with preveneered stainless steel crowns. [2019]

4. England 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. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

The use of stainless steel crowns. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Comparison of Three Esthetic Full-Coverage Restorations in Primary Maxillary Incisors at 12 Months. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Stainless steel crowns as a restoration for permanent posterior teeth in people with special needs: A retrospective study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Retrospective Study of Retention of Stainless Steel Crowns and Pre-veneered Crowns on Primary Anterior Teeth. [2018]

9. England pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. [2016]