Indirect Pulp CapPhase 4NCT04863222
Clinical and Radiographic Success of MTA vs Biodentine
A Phase 4 study testing Biodentine and mineral trioxide aggregate (MTA) in people with Indirect Pulp Cap and Pulpotomy, run by Geisinger Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Indirect Pulp Cap, Pulpotomy
- What is being tested?
- Biodentine and mineral trioxide aggregate (MTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2021to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female patients ages of 2 to ≤12 years.
- Bilateral symptomatic or asymptomatic vital primary molars with caries approximating or into the pulp.
- Patient who need a pulpotomy and/or indirect pulp cap treatments in two or more quadrants.
- Parents of patients who can provide consent in English.
- Patients who need treatment in an operating room setting at Geisinger.
Who cannot join
- Pre-operative radiographic or clinical symptoms associated with irreversible pulpitis or necrotic pulp.
- Radiographs not displaying furcation region of the tooth.
- Patients with cardiac conditions who need prophylaxis for infective Endocarditis.
- Patients with any type of cancer in the past or present.
- Non-restorable molars.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Geisinger
Danville, Pennsylvania, 17822
Gayatri Malik, DMD
About this study
Official title: Clinical and Radiographic Success of Mineral Trioxide Aggregate (MTA) vs Septodont Biodentine in Primary Molars in Pulpotomy and Indirect Pulp Cap Treatments
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.
Read the detailed description
This is a interventional randomized split mouth prospective study that evaluates the clinical and radiographic success of mineral trioxide aggregate (MTA) and Biodentine as pulpotomy and indirect pulp cap (IPC) medicaments. Male and female participants ages two to twelve who need at least two quadrants of treatment will be enrolled in the trial. Participants will be treated at Geisinger Medical Center, Danville, and Geisinger Bloomsburg Hospital operating rooms for full mouth rehabilitation. Each participant must have at least two matched bilateral carious primary molars that require either pulpotomy or indirect pulp cap. Maxillary and mandibular primary first and second molars who receive pulpotomy and /or indirect pulp cap will be compared. The research will be split mouth design where the primary molar on one side will get MTA as the pulpotomy or IPC medicament and the corresponding primary on the other side will get Biodentine as the pulpotomy or IPC medicament in the same arch.
The procedures will be performed according to standards of the American Academy of Pediatric Dentistry (AAPD), by Institutional Review Board approved investigators. Data will be extracted from the electronic health record (EHR) and TigerView dental radiograph imaging software. Data will be recorded using REDCap. Clinical and radiographic follow up of patients will be every 6 months since date of procedure for 3 years. Follow up will be done at the Geisinger Pediatric Dental Clinic at Danville or Milton.
- Conditions
- Indirect Pulp Cap, Pulpotomy
- Being tested
- Biodentine, mineral trioxide aggregate (MTA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDevice
During a patients procedure, one tooth will receive Biodentine instead of MTA.
mineral trioxide aggregate (MTA)Biological
mineral trioxide aggregate (MTA)
| Study group | Role | What they receive |
|---|---|---|
| MTA, then Biodentine | Experimental | 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. Receives: Device: Biodentine; Biological: mineral trioxide aggregate (MTA) |
| Biodentine, then MTA | Experimental | 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. Receives: Device: Biodentine; Biological: mineral trioxide aggregate (MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical success in pulpotomies and indirect pulp caps
To compare the rate of clinical success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years to clinically evaluate if the treatment was successful, if any discoloration has occurred and assess for any signs or symptoms of an abscess.
Measured: 4 years
Rate of radiographic success in pulpotomies and indirect pulp caps
To compare the rate of radiographic success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years where x-rays will be taken to determine if any abscess have formed.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start12 Nov 2021
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Pulp CapStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 646 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gayatri Malik, DMD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863222
- Sponsor's protocol ID
- 2019-0994
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success of Mineral Trioxide Aggregate (MTA) vs Septodont Biodentine in Primary Molars in Pulpotomy and Indirect Pulp Cap Treatments
- ClinicalTrials.gov ID
- NCT04863222
- Acronym / sponsor ID
- 2019-0994
- Conditions
- Indirect Pulp Cap, Pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 646 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a interventional randomized split mouth prospective study that evaluates the clinical and radiographic success of mineral trioxide aggregate (MTA) and Biodentine as pulpotomy and indirect pulp cap (IPC) medicaments. Male and female participants ages two to twelve who need at least two quadrants of treatment will be enrolled in the trial. Participants will be treated at Geisinger Medical Center, Danville, and Geisinger Bloomsburg Hospital operating rooms for full mouth rehabilitation. Each participant must have at least two matched bilateral carious primary molars that require either pulpotomy or indirect pulp cap. Maxillary and mandibular primary first and second molars who receive pulpotomy and /or indirect pulp cap will be compared. The research will be split mouth design where the primary molar on one side will get MTA as the pulpotomy or IPC medicament and the corresponding primary on the other side will get Biodentine as the pulpotomy or IPC medicament in the same arch.
The procedures will be performed according to standards of the American Academy of Pediatric Dentistry (AAPD), by Institutional Review Board approved investigators. Data will be extracted from the electronic health record (EHR) and TigerView dental radiograph imaging software. Data will be recorded using REDCap. Clinical and radiographic follow up of patients will be every 6 months since date of procedure for 3 years. Follow up will be done at the Geisinger Pediatric Dental Clinic at Danville or Milton.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA, then Biodentine | Experimental | Device: Biodentine, Biological: mineral trioxide aggregate (MTA)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. |
| Biodentine, then MTA | Experimental | Device: Biodentine, Biological: mineral trioxide aggregate (MTA)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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female patients ages of 2 to ≤12 years.
- Bilateral symptomatic or asymptomatic vital primary molars with caries approximating or into the pulp.
- Patient who need a pulpotomy and/or indirect pulp cap treatments in two or more quadrants.
- Parents of patients who can provide consent in English.
- Patients who need treatment in an operating room setting at Geisinger.
Key exclusion criteria (5 listed)
- Pre-operative radiographic or clinical symptoms associated with irreversible pulpitis or necrotic pulp.
- Radiographs not displaying furcation region of the tooth.
- Patients with cardiac conditions who need prophylaxis for infective Endocarditis.
- Patients with any type of cancer in the past or present.
- Non-restorable molars.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiodentineDuring a patients procedure, one tooth will receive Biodentine instead of MTA. | Device | Biodentine, then MTA, MTA, then Biodentine |
| mineral trioxide aggregate (MTA)mineral trioxide aggregate (MTA) | Biological | Biodentine, then MTA, MTA, then Biodentine |
Primary outcome
Rate of clinical success in pulpotomies and indirect pulp caps
Time frame: 4 years
To compare the rate of clinical success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years to clinically evaluate if the treatment was successful, if any discoloration has occurred and assess for any signs or symptoms of an abscess.
Rate of radiographic success in pulpotomies and indirect pulp caps
Time frame: 4 years
To compare the rate of radiographic success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years where x-rays will be taken to determine if any abscess have formed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gayatri Malik, DMD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biodentine and mineral trioxide aggregate (MTA) in people with Indirect Pulp Cap and Pulpotomy, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gayatri Malik, DMD (570-271-6355, gmalik1@geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical success in pulpotomies and indirect pulp caps (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.