Vital Pulp TherapiesPhase 4NCT02298504
Vital Pulp Treatment in Primary Teeth
A Phase 4 study testing Mineral Trioxide Aggregate, Biodentin and Vitrebond in people with Vital Pulp Therapies and Indirect Pulp Cap, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the… Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapies, Indirect Pulp Cap, Pulpotomy
- What is being tested?
- Mineral Trioxide Aggregate, Biodentin and Vitrebond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 14 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients with deep dental decay in primary molars
- Teeth with signs and symptoms of reversible pulpitis
Who cannot join
- Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection
- Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease
- Teeth that are not restorable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21043
About this study
Official title: Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth
In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.
Read the detailed description
Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, >50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups:
Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries.
Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry.
Twice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted.
The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.
- Conditions
- Vital Pulp Therapies, Indirect Pulp Cap, Pulpotomy
- Being tested
- Mineral Trioxide Aggregate, Biodentin, Vitrebond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide AggregateDrug
Also called MTA pulpotomy
Vital pulp therapy
BiodentinDrug
Also called Biodentin Pulpotomy
Vital pulp therapy
VitrebondDevice
Also called Indirect pulp cap
Vital pulp therapy
| Study group | Role | What they receive |
|---|---|---|
| Indirect pulp cap | Experimental | IDP will be performed for this group Receives: Device: Vitrebond |
| MTA pulpotomy | Experimental | MTA pulpotomy will be performed for this group Receives: Drug: Mineral Trioxide Aggregate |
| Biodentin pulpotomy | Experimental | Biodentin pulpotomy will be performed for this group Receives: Drug: Biodentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success after pulpotomy
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
Measured: 3 years
Clinical success after indirect pulp cap
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
Measured: 3 years
Radiographic success after pulpotomy
No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start1 Jul 2018
- Primary completion14 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapiesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vineet Dhar, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298504
- Sponsor's protocol ID
- HP-00058711
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2014
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth
- ClinicalTrials.gov ID
- NCT02298504
- Acronym / sponsor ID
- HP-00058711
- Conditions
- Vital Pulp Therapies, Indirect Pulp Cap, Pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.
Detailed description
Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, >50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups:
Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries.
Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry.
Twice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted.
The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indirect pulp cap | Experimental | Device: VitrebondIDP will be performed for this group |
| MTA pulpotomy | Experimental | Drug: Mineral Trioxide AggregateMTA pulpotomy will be performed for this group |
| Biodentin pulpotomy | Experimental | Drug: BiodentinBiodentin pulpotomy will be performed for this group |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients with deep dental decay in primary molars
- Teeth with signs and symptoms of reversible pulpitis
Key exclusion criteria (3 listed)
- Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection
- Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease
- Teeth that are not restorable
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 |
|---|---|---|
| Mineral Trioxide AggregateAlso: MTA pulpotomyVital pulp therapy | Drug | MTA pulpotomy |
| BiodentinAlso: Biodentin PulpotomyVital pulp therapy | Drug | Biodentin pulpotomy |
| VitrebondAlso: Indirect pulp capVital pulp therapy | Device | Indirect pulp cap |
Primary outcome
Clinical success after pulpotomy
Time frame: 3 years
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
Clinical success after indirect pulp cap
Time frame: 3 years
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
Radiographic success after pulpotomy
Time frame: 3 years
No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Vital Pulp Therapies
Not yet recruitingObservational study
Age-Related Inflammatory Proteins as Indicators of Vital Pulp Therapy Outcomes
Vital Pulp Therapy
Not yet recruitingObservational study
Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
Vital Pulp Therapies, pH
Enrolling by invitation
Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth.
Post-operative Pain, Vital Pulp Therapy
Active, not recruiting
Comparison of Sodium Hypochlorite Gel and Solution With and Without Nanoparticles for Postoperative Pain After Pulpotomy in Permanent Mandibular Molars
Vital Pulp Therapies, Pulpotomy
Enrolling by invitation
Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth.
Postoperative Pain, Vital Pulp Therapies
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Mineral Trioxide Aggregate, Biodentin and Vitrebond in people with Vital Pulp Therapies and Indirect Pulp Cap, run by University of Maryland, Baltimore 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success after pulpotomy (time frame: 3 years). The study lists 3 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.