Dental Crowns for Tooth Decay

Overseen By Patrick Ruck, DDS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Red dye allergy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of dental crowns for children with cavities requiring full coverage: a white flexible crown (BioFLX) and a silver metal crown (Stainless Steel Crown). Researchers aim to determine if the new white crown performs as well as the traditional silver one, commonly used for children. The study is suitable for children needing extensive dental work under general anesthesia and having certain tooth conditions, such as extensive decay or defects. Participants must attend follow-up appointments after the procedure. As an unphased trial, this study offers a unique opportunity for participants to contribute to advancing dental care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these dental crowns are safe for use in pediatric dentistry?

Research has shown that BioFLX crowns have achieved good results in short-term studies. Many patients found them easy to chew with and appreciated their appearance. However, specific safety information for BioFLX crowns is not yet available, which is important to consider when thinking about joining this trial.

Stainless steel crowns, familiar to many, have been used successfully in children's dentistry for a long time. They are safe and effective, serving as the standard choice for treating cavities in kids. The trial aims to determine if BioFLX crowns, which are white and flexible, can perform as well as these well-known metal crowns.

In summary, while BioFLX crowns appear promising in terms of function and appearance, more safety information is needed. Stainless steel crowns have a proven safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BioFLX crowns because they offer a potentially more adaptable and comfortable solution for tooth decay compared to traditional stainless steel crowns (SSC). Unlike the rigid material of SSCs, BioFLX crowns are designed to flex and conform more naturally to the tooth's shape, which could enhance comfort and fit. This flexibility might also reduce the risk of irritation and improve the overall durability of the crown, providing a more patient-friendly option for dental restorations.

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

Research shows that BioFLX crowns, one of the treatments in this trial, perform well for dental repairs. Early results indicate that 90% of patients report high satisfaction with their chewing ability, and all appreciate the appearance. BioFLX crowns also wear down less than zirconia crowns, suggesting they might last longer. Studies suggest these crowns effectively restore the shape and function of teeth, making them a promising choice for fixing cavities. Although more long-term data is needed, early findings encourage the use of BioFLX crowns for treating tooth decay. Participants in this trial will receive BioFLX crowns on one side of the mouth and 3M Stainless Steel Crowns on the opposite side, allowing for a direct comparison of these treatments. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children with cavities needing crowns, specifically those recommended to undergo dental procedures under anesthesia. It aims to compare a new white flexible crown (BioFLX) with the traditional silver metal crown (Stainless Steel Crown or SSC) used in pediatric dentistry.

Inclusion Criteria

All participants being ASA I or ASA II as defined by the American Society of Anesthesiologists

Patients qualifying for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC)

Participants meeting the criteria for full coverage and high caries risk as per AAPD Best Practice Guidelines

Exclusion Criteria

Participants not meeting the inclusion criteria

Patients with red dye allergy

My teeth do not qualify for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BioFLX or Stainless Steel Crowns under general anesthesia in a split-mouth design

1 day

1 visit (in-person)

Follow-up

Participants are monitored for gingival health, plaque retention, occlusal wear, and crown retention

36 months

Regular dental check-ups

What Are the Treatments Tested in This Trial?

Interventions

• BioFLX

Trial Overview The study tests BioFLX, a new type of white dental crown designed for primary molar teeth, against the standard Stainless Steel Crowns. The goal is to determine if BioFLX performs equally well over a period of 36 months in terms of durability and effectiveness.

How Is the Trial Designed?

Group I: SSC Experimental Treatment 1 Intervention

Experimental: 3M Stainless Steel Crowns. In this split-mouth design, subjects were randomly assigned to receive SSC in the left or right side of the mouth.

Group II: BioFLX Crown Experimental Treatment 1 Intervention

Experimental: BioFLX Crowns. In this split-mouth design, subjects were randomly assigned to receive BioFLX crowns on the side opposite of the 3M Stainless Steel Crowns.

BioFLX is already approved in United States, European Union for the following indications:

Approved in United States as Bioflx Crowns for:

• Primary molar teeth restoration
• Extensive tooth decay
• Fractured or broken teeth
• Hypoplastic teeth
• Teeth with developmental anomalies

Approved in European Union as Bioflx Crowns for:

• Primary molar teeth restoration
• Extensive tooth decay
• Fractured or broken teeth
• Hypoplastic teeth
• Teeth with developmental anomalies

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

In a study involving 15 human molars, both glass-ionomer cement and calcium-silicate cement were found to be effective as dentine substitutes, demonstrating good bioactivity and sealing properties.

Particulate bioglass showed poor cavity adaptation due to its larger particle size, suggesting that smaller particle sizes may improve its effectiveness in tooth repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interfacial properties of three different bioactive dentine substitutes. Gjorgievska, ES., Nicholson, JW., Apostolska, SM., et al.[2022]

New bioactive dental polymers are being developed that not only restore decayed tooth structures but also actively inhibit harmful biofilms and pathogens, addressing a major challenge in dental restoration failures.

These innovative materials significantly reduce biofilm growth and acid production, showing potential to prevent tooth decay and recurrent caries, which could greatly improve dental health outcomes and reduce the financial burden of dental restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a New Generation of Therapeutic Dental Polymers to Inhibit Oral Biofilms and Protect Teeth. Zhang, K., Baras, B., Lynch, CD., et al.[2020]

Out of 207 patients surveyed, 51 reported health improvements after having their dental materials replaced, indicating that replacing certain dental materials may lead to better health outcomes for some individuals.

Among the 31 patients who were specifically recommended to replace their dental materials, 24 followed through with the recommendation, suggesting that guidance from the Dental Biomaterials Adverse Reaction Unit plays a significant role in patients' decisions regarding dental restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' choice of dental treatment following examination at a specialty unit for adverse reactions to dental materials. Lygre, GB., Gjerdet, NR., Björkman, L.[2019]

Novel bioactive restorations have been developed to inhibit secondary caries in enamel and dentin, showing promise in both in vitro and in vivo biofilm models, which are effective for evaluating their efficacy.

There is a critical need for more intelligent and pH-responsive materials to enhance the prevention of secondary caries, as current bioactive materials need further evaluation in clinically relevant biofilm models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel bioactive dental restorations to inhibit secondary caries in enamel and dentin under oral biofilms. Zhou, W., Chen, H., Weir, MD., et al.[2023]

Activa BioActive-Restorative showed the highest potential for remineralisation of demineralised dentine, with a significant increase in calcium:phosphate ratio and hardness compared to Beautifil II and glass-ionomer restorations.

The study involved ten non-carious extracted molar teeth, which were partially demineralised and then restored with different materials, demonstrating that Activa BioActive-Restorative is the most effective option for enhancing dentine remineralisation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of remineralisation potentials of bioactive dental composite using an in-vitro demineralised dentine model. Sajini, SI., Alshawi, BA., Alharbi, LM.[2022]

A new procedure using a custom-made template and plastic foil allows for the accurate reproduction of internal contours of existing crowns, facilitating the rebuilding of composite core foundations for teeth that have undergone endodontic treatment.

This method addresses challenges faced when retrofitting existing crowns after core fractures or recurrent caries, improving the efficiency and effectiveness of dental restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rebuilding core foundations for existing crowns using a custom-made template. Berksun, S.[2005]

A study of 296 patients at the Norwegian National Dental Biomaterials Adverse Reaction Unit found that dental amalgam was the primary concern for 85% of referrals, with many patients reporting general symptoms like muscle pain and fatigue.

Patch testing revealed that a significant number of patients had allergies to metals commonly found in dental materials, but no clear cause-and-effect relationship was established between dental materials and the reported symptoms, indicating the need for a multidisciplinary approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four years of clinical experience with an adverse reaction unit for dental biomaterials. Vamnes, JS., Lygre, GB., Grönningsaeter, AG., et al.[2013]

The dual-cure universal adhesive system, Futurabond U, demonstrated reliable clinical performance in non-carious cervical lesions (NCCLs) after 36 months, with retention rates ranging from 87% to 94% across different application strategies.

No postoperative sensitivity or caries recurrence was observed, indicating the safety of the adhesive system, although greater marginal discrepancies were noted in the self-etch groups compared to other strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Universal Simplified Adhesive applied under different bonding technique's: 36-month Randomized Multicentre Clinical Trial. de Albuquerque, EG., Warol, F., Tardem, C., et al.[2022]

A case study demonstrated that using an allogeneic tooth fragment for restoring a maxillary first premolar resulted in a stable restoration after 12 months, with no signs of caries or fragment migration.

This approach to biological restoration effectively reestablishes both function and aesthetics in damaged teeth, suggesting it as a viable alternative to traditional restorative methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological restoration: a 4/5 crown. de Carvalho, MF., Botelho, AM., Tavano, KT., et al.[2013]

In a randomized trial involving 41 patients, the clinical performance of nanofill, a nanohybrid, and a microhybrid composite in posterior tooth restorations was evaluated over 12 months.

The study found that the materials used showed acceptable clinical performance after one year, suggesting they are a viable option for dental restorations, although further long-term evaluations are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of nanofill and nanohybrid composite in Class I restorations: a 12-month randomized trial. Andrade, AK., Duarte, RM., Silva, FD., et al.[2012]

In a study involving 40 extracted permanent teeth, NuSmile® ZR crowns showed significantly less microleakage when cemented with BioCem compared to when they were cemented with Ketac Cem.

BioCem cement was found to be more effective in reducing microleakage in zirconia crowns than Ketac Cem, indicating that the choice of cement can impact the effectiveness of dental crowns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microleakage of Cements in Prefabricated Zirconia Crowns. Stepp, P., Morrow, BR., Wells, M., et al.[2018]

The newly synthesized BIS-GMA based Chitra's Dental Material was tested for skin sensitization using the skin Maximization test in guinea pigs, demonstrating no sensitization potential.

The results indicate that this dental material is safe for clinical use, meeting the criteria for dental restorative materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin sensitization study of a new BIS-GMA based dental restorative material. Rathinam, K., Mohanan, PV.[2019]

Citations

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

BioFlx Pediatric Crowns: Current Evidence on Clinical ... Wear resistance studies reveal divergent brand-specific outcomes: Kids-e-Dental BioFlx crowns demonstrated less wear than zirconia [28] ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06897020

Child and Parental Satisfaction of Bioflx Crowns Compared ... The goal of this clinical trial is to evaluate the child and parents satisfaction of Bioflx crowns compared to zirconia crowns in the restoration of primary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320795/

Esthetics in Pediatric Dentistry—BioFlx Crowns: Case Series The crown is considered the most effective restoration for the management of dental caries. It reproduces the morphology and contour of the damaged coronal ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ipd.70039?af=R

Short‐Term Clinical Evaluation of Bioflx Crowns for Primary ... Preliminary short-term results showing favorable clinical outcomes (90% for “excellent” masticatory ability, 100% for positive esthetics and ...

5. withpower.com withpower.com/trial/phase-dental-caries-4-2024-1269f

Dental Crowns for Tooth Decay The goal is to determine if BioFLX performs equally well over a period of 36 months in terms of durability and effectiveness. How Is the Trial Designed? 2 ...

6. jocpd.com jocpd.com/articles/10.22514/jocpd.2024.132/htm

Journal of Clinical Pediatric Dentistry (JOCPD) The present study compared the shear stresses generated by BioFlx crowns, ZCs and the gold standard SSCs when restoring extensively decayed deciduous teeth ...