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

Trial Summary

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 data supports the effectiveness of the treatment BioFLX, Bioflx Crowns, NuSmile BioFlx, Prefabricated Resin Crowns for tooth decay?

Research on bioactive dental restorations shows they can help prevent further tooth decay by inhibiting secondary caries (new cavities) under biofilms (layers of bacteria). Additionally, studies on similar materials like glass-ionomer and calcium-silicate cements indicate they perform well in tooth repair by forming strong bonds with the tooth. ^{1 2 3 4 5}

Is the use of dental crowns for tooth decay safe?

There is no specific safety data available for the dental crowns mentioned, but a study from a Norwegian unit found that some patients experienced health improvements after replacing dental materials, while a few felt worse. This suggests that reactions to dental materials can vary among individuals. ^{1 6 7 8 9}

What makes the BioFLX treatment for dental crowns unique compared to other treatments for tooth decay?

BioFLX crowns are unique because they are made from bioactive materials that not only restore the tooth but also help prevent further decay by inhibiting harmful biofilms and promoting remineralization, unlike traditional crowns that are typically bioinert. ^{3 4 10 11 12}

What is the purpose of this trial?

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 (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.

Eligibility Criteria

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)

My child is between 2 and 5 years old and needs full mouth dental care at a CCHMC clinic.

Exclusion Criteria

Participants not meeting the inclusion criteria

Patients with red dye allergy

My teeth do not qualify for the study.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Clinical evaluation of nanofill and nanohybrid composite in Class I restorations: a 12-month randomized trial. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Universal Simplified Adhesive applied under different bonding technique's: 36-month Randomized Multicentre Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Interfacial properties of three different bioactive dentine substitutes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Novel bioactive dental restorations to inhibit secondary caries in enamel and dentin under oral biofilms. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Biological restoration: a 4/5 crown. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Patients' choice of dental treatment following examination at a specialty unit for adverse reactions to dental materials. [2019]

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

Microleakage of Cements in Prefabricated Zirconia Crowns. [2018]

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

Skin sensitization study of a new BIS-GMA based dental restorative material. [2019]

9. Denmark pubmed.ncbi.nlm.nih.gov

Four years of clinical experience with an adverse reaction unit for dental biomaterials. [2013]

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Assessment of remineralisation potentials of bioactive dental composite using an in-vitro demineralised dentine model. [2022]

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

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

12. Switzerland pubmed.ncbi.nlm.nih.gov

Developing a New Generation of Therapeutic Dental Polymers to Inhibit Oral Biofilms and Protect Teeth. [2020]