Pulpotomies on Primary MolarsNCT04962607
Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth
An observational study of Pulpotomies on Primary Molars, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC). Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomies on Primary Molars
- What is being tested?
- Neo-Putty® as dressing agents in pulpotomized primary molars
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2021to 1 Jan 2026
- Phase
- Observational
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem
Who may be able to join
- primary teeth which requires pulpotomy.
Who cannot join
- not healthy patients,
- teeth which requires pulpectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) Versus Formocresol as Dressing Agents in Pulpotomized Primary Molars
The objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC).
- Conditions
- Pulpotomies on Primary Molars
- Being tested
- Neo-Putty® as dressing agents in pulpotomized primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-Putty® as dressing agents in pulpotomized primary molarsOther
Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany).
In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM
| Study group | Role | What they receive |
|---|---|---|
| Study Group | 1. Asymptomatic primary molars with deep carious lesions scheduled for regular treatment.
2. Exposure of a vital pulp due to caries.
3. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract.
4. The possibility of proper restoration of the teeth. Receives: Other: Neo-Putty® as dressing agents in pulpotomized primary molars | |
| control group | 1. Asymptomatic primary molars with deep carious lesions scheduled for regular treatment.
2. Exposure of a vital pulp due to caries.
3. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract.
4. The possibility of proper restoration of the teeth. Receives: Other: Neo-Putty® as dressing agents in pulpotomized primary molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the primary molar pulpotomy
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpotomies on Primary MolarsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962607
- Sponsor's protocol ID
- 0994-20-HMO
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) Versus Formocresol as Dressing Agents in Pulpotomized Primary Molars
- ClinicalTrials.gov ID
- NCT04962607
- Acronym / sponsor ID
- 0994-20-HMO
- Conditions
- Pulpotomies on Primary Molars
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 15 Jul 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 objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Neo-Putty® as dressing agents in pulpotomized primary molars1. Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. 2. Exposure of a vital pulp due to caries. 3. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. 4. The possibility of proper restoration of the teeth. |
| control group | – | Other: Neo-Putty® as dressing agents in pulpotomized primary molars1. Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. 2. Exposure of a vital pulp due to caries. 3. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. 4. The possibility of proper restoration of the teeth. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem
Key inclusion criteria (1 listed)
- primary teeth which requires pulpotomy.
Key exclusion criteria (2 listed)
- not healthy patients,
- teeth which requires pulpectomy.
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 |
|---|---|---|
| Neo-Putty® as dressing agents in pulpotomized primary molarsFollowing removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany). In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM | Other | Study Group, control group |
Primary outcome
Success rate of the primary molar pulpotomy
Time frame: One year
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 13 Jun 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. 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?
An observational study of Pulpotomies on Primary Molars, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 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 Israel. 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.
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?
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?
Success rate of the primary molar pulpotomy (time frame: One year). 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 13 Jun 2025.