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

Trial Summary

What is the purpose of this trial?

The purpose of this prospective study is to compare the clinical and radiographic success of MTA and Biodentine as a medicament in vital pulp therapy in maxillary and mandibular primary molars in a pediatric population. There is limited research currently on Biodentine since it's a novel product. Biodentine is less expensive than MTA and does not cause discoloration like MTA. Biodentine may be an alternative medicament used for vital pulp therapy in primary molars.

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 data supports the effectiveness of the treatment Biodentine vs MTA for dental cavities?

Research shows that both Biodentine and MTA are effective in treating dental cavities, with MTA having better bond strength to restorative materials, while Biodentine offers advantages like faster setting and no staining. ^{1 2 3 4 5}

Is Biodentine or MTA safe for use in dental treatments?

Research shows that both Biodentine and MTA are generally safe for use in dental treatments, as they are biocompatible (do not harm living tissue) and do not cause significant inflammatory responses in human dental pulp cells. ^{1 4 5 6 7}

How does the treatment Biodentine differ from other treatments for dental cavities?

Biodentine is unique because it sets faster and does not cause tooth discoloration compared to traditional Mineral Trioxide Aggregate (MTA), making it a promising alternative for dental cavity treatment. ^{1 2 7 8 9}

Research Team

Gayatri Malik, DMD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

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

Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Shear bond strength of different restorative materials to mineral trioxide aggregate and Biodentine. [2022]

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

Expression of Mineralization Markers during Pulp Response to Biodentine and Mineral Trioxide Aggregate. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Bone tissue reaction, setting time, solubility, and pH of root repair materials. [2020]

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

Cell Viability and Tissue Reaction of NeoMTA Plus: An In Vitro and In Vivo Study. [2019]

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

Effects of calcium silicate endodontic cements on biocompatibility and mineralization-inducing potentials in human dental pulp cells. [2022]

7. United States 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. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Biodentine versus mineral trioxide aggregate as a direct pulp capping material for human mature permanent teeth - A systematic review. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Comparative evaluation of sealing ability and microstructure of MTA and Biodentine after exposure to different environments. [2022]