Irreversible PulpitisNCT06903013
Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis
A study testing Non vitalPulp therapy and Vital pulp therapy in people with Irreversible Pulpitis, run by Minia University.
Trial summary
Study will evaluate and compare post operative pain for primary molars with irreversible pulpitis after pulpotomy and pulpuectomy Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Non vitalPulp therapy and Vital pulp therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2025to 30 Oct 2025
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy individual
- Has primary tooth with irreversible pulpitis
- Cooperative child
Who cannot join
- Mentally, physically or medically compromised children
- Uncooperative children
About this study
Official title: Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis a Parallel Randomized Clinical Trial
Study will evaluate and compare post operative pain for primary molars with irreversible pulpitis after pulpotomy and pulpuectomy
- Conditions
- Irreversible Pulpitis
- Being tested
- Non vitalPulp therapy, Vital pulp therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non vitalPulp therapyOther
Pulp therapy deals about management of inflamed vital dental pulp With complete pulp removal and obturation with resorbable materi
Vital pulp therapyOther
Pulp therapy through partial root removal and using of regenerative capping material
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Vital pulpotomy using regenerative materials Receives: Other: Vital pulp therapy |
| Pulpectomy | Active comparator | Not described Receives: Other: Non vitalPulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Post operative pain using pain scale after 1,2,7 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Minia 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903013
- Sponsor's protocol ID
- 1029
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis a Parallel Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06903013
- Acronym / sponsor ID
- 1029
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 30 Mar 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.
Study will evaluate and compare post operative pain for primary molars with irreversible pulpitis after pulpotomy and pulpuectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Other: Vital pulp therapyVital pulpotomy using regenerative materials |
| Pulpectomy | Active comparator | Other: Non vitalPulp therapy |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy individual
- Has primary tooth with irreversible pulpitis
- Cooperative child
Key exclusion criteria (2 listed)
- Mentally, physically or medically compromised children
- Uncooperative children
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 |
|---|---|---|
| Non vitalPulp therapyPulp therapy deals about management of inflamed vital dental pulp With complete pulp removal and obturation with resorbable materi | Other | Pulpectomy |
| Vital pulp therapyPulp therapy through partial root removal and using of regenerative capping material | Other | Pulpotomy |
Primary outcome
Post operative pain
Time frame: 6 months
Post operative pain using pain scale after 1,2,7 days
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 30 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non vitalPulp therapy and Vital pulp therapy in people with Irreversible Pulpitis, run by Minia 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 3 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: opening soon, as of the sponsor's last update on 30 Mar 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?
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?
Post operative pain (time frame: 6 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 30 Mar 2025.