Pulpitis - IrreversibleNCT06922578
Clinical and Radiographic Success of Pulpotomy Using Neoputty Mineral Trioxide Aggregate Versus Pulpectomy Using Endoflas In Primary Molars With Irreversible Pulpitis: A Randomized Controlled Trial
A study testing NeoPUTTY MTA pulpotomy and Endoflas pulpectomy in people with Pulpitis - Irreversible, run by Cairo University.
Trial summary
The goal of this randomized clinical trial is to evaluate the clinical and radiographic success of pulpotomy using Neoputty MTA vital primary molars diagnosed with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- NeoPUTTY MTA pulpotomy and Endoflas pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jun 2026
- Phase
- Interventional
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with spontaneous pain lasting a few seconds to several hours.
- Pain is intensified by thermal stimulus and persists after its removal.
- Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
- Radicular pulp health is verified by achieving hemostasis within six minutes of compression using a cotton pellet with 2% sodium hypochlorite.
- Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.
Who cannot join
- Unrestorable primary molars.
- Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this randomized clinical trial is to evaluate the clinical and radiographic success of pulpotomy using Neoputty MTA vital primary molars diagnosed with symptomatic irreversible pulpitis.
The main question it aims to answer is:
Will Neoputty MTA pulpotomy have higher clinical and radiographic success in comparison to Endoflas pulpectomy in primary molars with irreversible pulpitis?
- Conditions
- Pulpitis - Irreversible
- Being tested
- NeoPUTTY MTA pulpotomy, Endoflas pulpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPUTTY MTA pulpotomyProcedure or surgery
Neoputty MTA pulpotomy performed in vital primary molars with symptomatic irreversible pulpitis
Endoflas pulpectomyProcedure or surgery
Endoflas pulpectomy in vital primary molars with symptomatic irreversible pulpitis
| Study group | Role | What they receive |
|---|---|---|
| Neoputty MTA pulpotomy | Experimental | Not described Receives: Procedure: NeoPUTTY MTA pulpotomy |
| Endoflas pulpectomy | Experimental | Not described Receives: Procedure: Endoflas pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
postoperative pain will be assessed using the visual analogue scale (VAS) within 24 hours, after 1 week, 3, 6, 9, and 12 months. The patients are asked to point to the face that best represents how they are feeling at the follow-up visits.
Measured: within 24 hours, after 1 week, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Motawie Abdulfattah, Cairo University
- Investigators
- DR, Principal investigator, assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922578
- Sponsor's protocol ID
- Neoputty MTA pulpotomy
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success of Pulpotomy Using Neoputty Mineral Trioxide Aggregate Versus Pulpectomy Using Endoflas In Primary Molars With Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06922578
- Acronym / sponsor ID
- Neoputty MTA pulpotomy
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Apr 2025 (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 goal of this randomized clinical trial is to evaluate the clinical and radiographic success of pulpotomy using Neoputty MTA vital primary molars diagnosed with symptomatic irreversible pulpitis.
The main question it aims to answer is:
Will Neoputty MTA pulpotomy have higher clinical and radiographic success in comparison to Endoflas pulpectomy in primary molars with irreversible pulpitis?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoputty MTA pulpotomy | Experimental | Procedure: NeoPUTTY MTA pulpotomy |
| Endoflas pulpectomy | Experimental | Procedure: Endoflas pulpectomy |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with spontaneous pain lasting a few seconds to several hours.
- Pain is intensified by thermal stimulus and persists after its removal.
- Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
- Radicular pulp health is verified by achieving hemostasis within six minutes of compression using a cotton pellet with 2% sodium hypochlorite.
- Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.
Key exclusion criteria (4 listed)
- Unrestorable primary molars.
- Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
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 |
|---|---|---|
| NeoPUTTY MTA pulpotomyNeoputty MTA pulpotomy performed in vital primary molars with symptomatic irreversible pulpitis | Procedure or surgery | Neoputty MTA pulpotomy |
| Endoflas pulpectomyEndoflas pulpectomy in vital primary molars with symptomatic irreversible pulpitis | Procedure or surgery | Endoflas pulpectomy |
Primary outcome
postoperative pain
Time frame: within 24 hours, after 1 week, 3, 6, 9, and 12 months
postoperative pain will be assessed using the visual analogue scale (VAS) within 24 hours, after 1 week, 3, 6, 9, and 12 months. The patients are asked to point to the face that best represents how they are feeling at the follow-up visits.
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 10 Apr 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.
DR principal investigator
assistant lecturer
Questions about this trial
What is this clinical trial studying?
A study testing NeoPUTTY MTA pulpotomy and Endoflas pulpectomy in people with Pulpitis - Irreversible, run by Cairo University.
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 4 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: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact manar motawie el nimr, masters (0201101778899, manar.motawie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: within 24 hours, after 1 week, 3, 6, 9, and 12 months). 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 10 Apr 2025.