Irreversible PulpitisNCT06679075
Clinical and Radiographic Evaluation of Propolis as a Hemostatic Agent in Full Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis
A study testing Full pulpotomy using propolis and bioceramic putty, Full pulpotomy using Propolis and MTA and Full pulpotomy using sodium hypochlorite and bioceramic putty in people with Irreversible Pulpitis, run by Misr International University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to assess the effectiveness of propolis as a hemostatic agent in full pulpotomy for mature permanent molars with irreversible pulpitis, compared to sodium hypochlorite (NaOCl). Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Full pulpotomy using propolis and bioceramic putty, Full pulpotomy using Propolis and MTA and Full pulpotomy using sodium hypochlorite and bioceramic putty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 16 Mar 2026
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants of both genders falling within the age range of 20 to 45 years.
- Presence of vital mature permanent molars diagnosed as irreversible pulpitis.
- Confirmation of vital bleeding pulp tissue in all canals following complete pulpotomy.
Who cannot join
- Non-vital teeth.
- Teeth with Immature roots.
- Uncontrolled pulpal bleeding persisting beyond 10 minutes post-application of sodium hypochlorite as a hemostatic agent.
- Insufficient bleeding post-pulp exposure, indicative of pulp degeneration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Propolis as a Hemostatic Agent in Full Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis Using Two Different Dressing Materials: A Randomized Clinical Trial
The goal of this randomized clinical trial is to assess the effectiveness of propolis as a hemostatic agent in full pulpotomy for mature permanent molars with irreversible pulpitis, compared to sodium hypochlorite (NaOCl). The study also compares how bioceramic putty performs compared to mineral trioxide aggregate (MTA) as pulpotomy dressing materials.
Participants will be randomly allocated into four groups (15 patients each) according to the hemostatic agent and dressing material used:
- Propolis + bioceramic putty
- Propolis + MTA
- Sodium hypochlorite + bioceramic putty
- Sodium hypochlorite + MTA Bleeding time and postoperative pain will be recorded. Clinical and radiographic success will be evaluated at 1, 3, and 6 months following treatment.
- Conditions
- Irreversible Pulpitis
- Being tested
- Full pulpotomy using propolis and bioceramic putty, Full pulpotomy using Propolis and MTA, Full pulpotomy using sodium hypochlorite and bioceramic putty, Full pulpotomy using sodium hypochlorite and MTA
- Keywords
- Pulpotomy, Vital Pulp Therapy, Irreversible Pulpitis, Hemostasis, Hemostatic Agent, Propolis, MTA, Bioceramic, Full Pulpotomy, Mineral Trioxide Aggregate, Mature Permanent Molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomy using propolis and bioceramic puttyProcedure or surgery
Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and bioceramic putty as a dressing material
Full pulpotomy using Propolis and MTAProcedure or surgery
Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and MTA as a dressing material
Full pulpotomy using sodium hypochlorite and bioceramic puttyProcedure or surgery
Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material
Full pulpotomy using sodium hypochlorite and MTAProcedure or surgery
Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material.
| Study group | Role | What they receive |
|---|---|---|
| Propolis + Bioceramic putty | Experimental | Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and bioceramic putty as a dressing material. Receives: Procedure: Full pulpotomy using propolis and bioceramic putty |
| Propolis + MTA | Experimental | Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and MTA as a dressing material. Receives: Procedure: Full pulpotomy using Propolis and MTA |
| Sodium hypochlorite + bioceramic putty | Experimental | Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material. Receives: Procedure: Full pulpotomy using sodium hypochlorite and bioceramic putty |
| Sodium hypochlorite + MTA | Active comparator | Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material Receives: Procedure: Full pulpotomy using sodium hypochlorite and MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success rate
Success rate of full pulpotomy procedure using different hemostatic agents and different dressing materials using the clinical and radiographic criteria for success and failure.
Measured: 1, 3, 6 months
Bleeding time
Recording the bleeding time of different participants during hemostasis.
Measured: During hemostasis (0-10 minutes)
Secondary outcomes (1)
Post-operative pain
Recording the post-operative pain using Heft-Parker visual analogue scale Minimum value: None Maximum value: Maximum possible The higher values indicate more post-operative pain
Measured: 24 hours, 3 days, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Nov 2024
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hisham Selim, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679075
- Sponsor's protocol ID
- MIU-IRB-2324-047
- Status last verified
- Aug 2026
- First submitted
- 6 Nov 2024
- Last updated
- 11 Aug 2026
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Propolis as a Hemostatic Agent in Full Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis Using Two Different Dressing Materials: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06679075
- Acronym / sponsor ID
- MIU-IRB-2324-047
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpotomy, Vital Pulp Therapy, Irreversible Pulpitis, Hemostasis, Hemostatic Agent, Propolis, MTA, Bioceramic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 7 Nov 2024 (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 assess the effectiveness of propolis as a hemostatic agent in full pulpotomy for mature permanent molars with irreversible pulpitis, compared to sodium hypochlorite (NaOCl). The study also compares how bioceramic putty performs compared to mineral trioxide aggregate (MTA) as pulpotomy dressing materials.
Participants will be randomly allocated into four groups (15 patients each) according to the hemostatic agent and dressing material used:
- Propolis + bioceramic putty
- Propolis + MTA
- Sodium hypochlorite + bioceramic putty
- Sodium hypochlorite + MTA Bleeding time and postoperative pain will be recorded. Clinical and radiographic success will be evaluated at 1, 3, and 6 months following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Propolis + Bioceramic putty | Experimental | Procedure: Full pulpotomy using propolis and bioceramic puttyAdult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and bioceramic putty as a dressing material. |
| Propolis + MTA | Experimental | Procedure: Full pulpotomy using Propolis and MTAAdult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and MTA as a dressing material. |
| Sodium hypochlorite + bioceramic putty | Experimental | Procedure: Full pulpotomy using sodium hypochlorite and bioceramic puttyAdult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material. |
| Sodium hypochlorite + MTA | Active comparator | Procedure: Full pulpotomy using sodium hypochlorite and MTAAdult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants of both genders falling within the age range of 20 to 45 years.
- Presence of vital mature permanent molars diagnosed as irreversible pulpitis.
- Confirmation of vital bleeding pulp tissue in all canals following complete pulpotomy.
Key exclusion criteria (4 listed)
- Non-vital teeth.
- Teeth with Immature roots.
- Uncontrolled pulpal bleeding persisting beyond 10 minutes post-application of sodium hypochlorite as a hemostatic agent.
- Insufficient bleeding post-pulp exposure, indicative of pulp degeneration.
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 |
|---|---|---|
| Full pulpotomy using propolis and bioceramic puttyFull Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and bioceramic putty as a dressing material | Procedure or surgery | Propolis + Bioceramic putty |
| Full pulpotomy using Propolis and MTAFull Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and MTA as a dressing material | Procedure or surgery | Propolis + MTA |
| Full pulpotomy using sodium hypochlorite and bioceramic puttyFull Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material | Procedure or surgery | Sodium hypochlorite + bioceramic putty |
| Full pulpotomy using sodium hypochlorite and MTAFull Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material. | Procedure or surgery | Sodium hypochlorite + MTA |
Primary outcome
Clinical and radiographic success rate
Time frame: 1, 3, 6 months
Success rate of full pulpotomy procedure using different hemostatic agents and different dressing materials using the clinical and radiographic criteria for success and failure.
Bleeding time
Time frame: During hemostasis (0-10 minutes)
Recording the bleeding time of different participants during hemostasis.
1 secondary outcome
Post-operative pain
Time frame: 24 hours, 3 days, 1 week
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 11 Aug 2026.
- 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?
A study testing Full pulpotomy using propolis and bioceramic putty, Full pulpotomy using Propolis and MTA and Full pulpotomy using sodium hypochlorite and bioceramic putty in people with Irreversible Pulpitis, run by Misr International University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 11 Aug 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 Egypt. 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?
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 and radiographic success rate (time frame: 1, 3, 6 months). 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 11 Aug 2026.