Biodentine vs MTA for Dental Cavities

Overseen By Gayatri Malik, DMD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Geisinger Clinic

Disqualifiers: Irreversible pulpitis, Necrotic pulp, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 day

646 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments, Biodentine and MTA (Mineral Trioxide Aggregate), for managing dental cavities in children's primary molars (baby teeth). The goal is to determine which treatment is more effective for vital pulp therapy, a procedure that preserves the tooth when decay is near or has reached the pulp (the soft tissue inside the tooth). Biodentine, a newer option, might be more affordable and does not stain teeth like MTA can. Children aged 2 to 12 who need cavity treatment on both sides of their mouth may be suitable candidates for this study. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, and this research aims to understand how they benefit more patients.

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 doctor.

What is the safety track record for Biodentine and MTA?

Research has shown that both Biodentine and MTA are generally safe for dental procedures. Past studies have demonstrated that patients tolerate Biodentine well, maintaining healthy tooth tissue. However, a rare report noted unexpected gum issues, such as tissue death and loss.

For MTA, studies indicate it is very effective and generally safe for dental treatments. Specifically, one study found a high success rate of 92.7% over three years for treating inflamed tooth pulp. MTA is known for its success in maintaining healthy teeth, though it can sometimes cause tooth discoloration.

Both treatments are considered safe based on past research, with most patients experiencing positive outcomes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Biodentine and MTA because these materials offer unique benefits for treating dental cavities. Unlike traditional fillings, Biodentine is a bioactive material that encourages natural dentin regeneration, potentially leading to healthier and more resilient teeth. MTA, on the other hand, is known for its excellent sealing properties and ability to set in moist conditions, which can be particularly beneficial in dental procedures. Both treatments aim to improve the longevity and effectiveness of dental restorations, making them promising alternatives to conventional options.

What evidence suggests that this trial's treatments could be effective for dental cavities?

This trial will compare Biodentine and MTA for treating dental cavities. Research has shown that Biodentine is promising, with success rates of 90% after one month, 85% after three months, and 80% after six months when used to cover and protect the tooth's nerve area. Biodentine also maintains its color and effectively fills deep cavities.

Conversely, MTA is a well-known treatment with a high success rate of 95% in sealing teeth and forming a protective layer. In this trial, participants will receive both treatments, with one molar treated with Biodentine and another with MTA, allowing for direct comparison. Clinical and X-ray evaluations have shown similar success rates for both Biodentine and MTA, making them strong options for treating cavities in children's molars. ^{3 6 7 8 9}

Who Is on the Research Team?

Gayatri Malik, DMD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for kids aged 2 to 12 with primary molars needing vital pulp therapy due to cavities close to or reaching the pulp. It's only for those who can get treatment at Geisinger and whose parents consent in English. Kids with irreversible tooth nerve damage, heart conditions requiring infection prevention, cancer history, or non-restorable molars cannot join.

Inclusion Criteria

I am between 2 and 12 years old.

I have tooth decay in my primary molars that may be affecting the tooth's pulp.

My child's legal guardian can consent in English.

Exclusion Criteria

I have severe tooth pain or signs of a dead tooth nerve.

My back teeth cannot be fixed.

I have or had cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pulpotomy or indirect pulp cap treatment using MTA or Biodentine in a split-mouth design

1 day

1 visit (in-person)

Follow-up

Participants are monitored for clinical and radiographic success every 6 months for 3 years

3 years

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biodentine
• MTA

Trial Overview The study compares MTA and Biodentine's effectiveness in treating children's molar teeth by assessing clinical outcomes and x-ray results after using these materials for vital pulp therapy. Biodentine could be a cheaper alternative that doesn't stain teeth like MTA.

How Is the Trial Designed?

Group I: MTA, then Biodentine Experimental Treatment 2 Interventions

The participant will receive the standard of care procedure using MTA in on a right primary molar. A left primary molar will then be treated using Biodentine.

Group II: Biodentine, then MTA Experimental Treatment 2 Interventions

Investigators will prepare and treat a participants right primary molar with Biodentine. The participant will then receive the standard of care procedure using MTA in on a left primary molar.

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

Approved in European Union as Biodentine for:

• Vital pulp therapy
• Pulp capping
• Partial pulpotomy
• Pulpotomy

Approved in United States as Biodentine for:

• Vital pulp therapy
• Pulp capping
• Partial pulpotomy
• Pulpotomy

Approved in Canada as Biodentine for:

• Vital pulp therapy
• Pulp capping
• Partial pulpotomy
• Pulpotomy

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Published Research Related to This Trial

In a study involving 104 human anterior teeth, it was found that blood contamination significantly increased tooth discoloration after using various calcium silicate-based cements, but all materials showed similar discoloration levels in the presence of blood.

When blood was not present, Biodentine and EndoSequence Root Repair Material (ERRM) caused significantly less discoloration compared to OrthoMTA, suggesting they may be better options for minimizing aesthetic changes in dental treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Comparison of Occurrence of Tooth Discoloration after the Application of Various Calcium Silicate-based Cements: An Ex Vivo Study. Shokouhinejad, N., Nekoofar, MH., Pirmoazen, S., et al.[2022]

In a study involving 68 vital permanent teeth with deep caries, both Biodentine and MTA showed comparable success rates for pulp capping, with a 93.3% success rate at 6 months and an increase to 100% at 2 years.

The long-term success of both materials was influenced by the remaining tooth structure and the durability of the coronal restoration, highlighting the importance of these factors in vital pulp therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. Awawdeh, L., Al-Qudah, A., Hamouri, H., et al.[2019]

NeoMTA Plus had longer setting times compared to MTA Angelus and Biodentine, but all materials demonstrated satisfactory physical-chemical properties for clinical use.

Biodentine exhibited the highest solubility and pH levels, while all three materials allowed for effective bone repair over time, indicating their potential as viable root repair materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone tissue reaction, setting time, solubility, and pH of root repair materials. Quintana, RM., Jardine, AP., Grechi, TR., et al.[2020]

In an acidic environment, Biodentine's ability to prevent fluid movement improved, while ProRoot MTA consistently showed superior sealing ability over time, especially in saline conditions.

Both materials underwent morphological changes when exposed to citric acid, with Biodentine developing a smoother surface and more spheroidal crystals, indicating that they can be effectively used in acidic conditions for dental applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of sealing ability and microstructure of MTA and Biodentine after exposure to different environments. Agrafioti, A., Tzimpoulas, N., Chatzitheodoridis, E., et al.[2022]

Biodentine and mineral trioxide aggregate (MTA) both showed similar effects on the viability of dental pulp cells, with no significant differences in cell viability after 24 and 48 hours of treatment.

Biodentine induced a more intense and widespread expression of mineralization markers, such as osteopontin, compared to MTA, suggesting it may promote better mineralization in dental pulp tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of Mineralization Markers during Pulp Response to Biodentine and Mineral Trioxide Aggregate. Daltoé, MO., Paula-Silva, FW., Faccioli, LH., et al.[2022]

Biodentine and mineral trioxide aggregate (MTA) are both effective materials for direct pulp capping in human permanent mature teeth, showing similar capabilities in promoting dentin bridge formation.

This conclusion is based on a systematic review of seven studies, indicating that while Biodentine performs comparably to MTA, more randomized clinical trials with larger sample sizes and longer follow-up are needed for stronger evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodentine versus mineral trioxide aggregate as a direct pulp capping material for human mature permanent teeth - A systematic review. Mahmoud, SH., El-Negoly, SA., Zaen El-Din, AM., et al.[2022]

NeoMTA Plus (NMP) demonstrated comparable cell viability and biocompatibility to mineral trioxide aggregate (MTA) and Biodentine (BD) in both in vitro and in vivo tests, indicating it is a safe option for dental applications.

While all materials showed reduced inflammation over time, Biodentine exhibited more intense inflammatory responses and less favorable tissue reactions compared to NMP and MTA, particularly at the 30-day mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell Viability and Tissue Reaction of NeoMTA Plus: An In Vitro and In Vivo Study. Pinheiro, LS., Iglesias, JE., Boijink, D., et al.[2019]

Biodentine, along with OMTA and AMTA, demonstrated good biocompatibility and odontoblastic potential in human dental pulp cells, showing similar effects to the traditional material IRM.

Biodentine and the other tested materials resulted in lower levels of proinflammatory mediators compared to IRM, suggesting they may be safer options for dental pulp capping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of calcium silicate endodontic cements on biocompatibility and mineralization-inducing potentials in human dental pulp cells. Chang, SW., Lee, SY., Ann, HJ., et al.[2022]

In a study comparing the bond strength of Biodentine and MTA to various restorative materials, MTA demonstrated superior shear bond strength (SBS) to composite resin and compomer materials, indicating its effectiveness in dental restorations.

Despite the advantages of Biodentine, MTA showed better bonding performance, suggesting that MTA may be the preferred choice for certain dental applications involving composite and compomer restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear bond strength of different restorative materials to mineral trioxide aggregate and Biodentine. Tulumbaci, F., Almaz, ME., Arikan, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4082844/

A Review on Biodentine, a Contemporary Dentine ... Favorable results were obtained for Portland Cement (PC) and Biodentine and these 2 materials demonstrated color stability over a period of 5 days. Based on ...

2. septodontusa.com septodontusa.com/media-content/biodentine-in-deep-caries-restoration-not-just-for-pulp-exposure/

Biodentine® in Deep Caries Restoration: Not Just for Pulp ... Indeed, Biodentine® is an excellent choice for deep caries with pulp exposure, demonstrating a range of success rates in teeth using Biodentine as a direct pulp ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225160/

Evaluation of Direct and Indirect Pulp Capping With ... The success rate of pulp capping was 90% at one month, 85% at three months, and 80% at six months. Conclusion: The results of the studies ...

4. septodont.com.pl septodont.com.pl/wp-content/uploads/sites/15/2024/04/Case-Studies-25.pdf?x50314

Biodentine™ BioRoot™ It is a dentine substitute suited for restoring a deep cavity using the “Bio-Bulk Fill” procedure, from the pulp to the tooth surface. BioRoot™ ...

5. septodontusa.com septodontusa.com/wp-content/uploads/2024/02/Biodentine-XP-BBF-Campaign-Wave-2-Case-Study-Dr.-Sabbagh.pdf?x89675

Deep caries management using Bio-Bulk Procedure The main advantage of Biodentine™ is that we can use it to fill the entire cavity, and thus it will simultaneously act as both the bioactive pulp-capping ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3536989/

Clinical evaluation of the performance and safety of a new ... It was found that the Biodentine restoration was well tolerated as all patients tested had a positive pulp vitality test. Biodentine was cut back using dental ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=12116552&pc=KIF

MAUDE Adverse Event Report: SEPTODONT SAS BIODENTINE Preliminary results and conclusion of manufacturer's investigation: the patient experienced gum necrosis and loss, unexpected for biodentine (biocompatible ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06802549

Outcomes of Partial Pulpotomy Treatment in Cariously ... The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It ...

9. septodontusa.com septodontusa.com/product/dentin-restoration-biodentine/

Biodentine – Bioactive Dentin Substitute ... - Septodont USA *No bacteriostatic properties can be claimed. Biodentine demonstrates color stability, with tests showing little to no tooth discoloration. Ordering information.