Pulpitis - IrreversibleNCT06597487
The Effect of Prognostic Factors on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis
A study testing Full pulpotomy and Conventional root canal treatment in people with Pulpitis - Irreversible, run by Misr International University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Full pulpotomy and Conventional root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 1 Jul 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mature permanent molars with irreversible pulpitis.
- Presence of bleeding pulp tissues from all canals.
- The tooth is not periodontally compromised.
Who cannot join
- Non-vital teeth.
- Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
- Molars with immature roots.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Wolters Classification of Pulpitis and the Radiographic Caries Depth Detected Using Artificial Intelligence on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis: A Randomized Controlled Trial
This study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis.
Read the detailed description
- Patients with mature permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
- The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
- Pre-operative radiographs will be taken, and radiographic caries depth will be assessed.
- An Artificial Intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure. The diagnostic accuracy of the software will be evaluated by comparing its readings with clinical findings of pulp exposure after caries removal.
- The patients will be randomized to receive either full pulpotomy or conventional root canal treatment.
- The patients will be followed up for 1, 3 and 6 months to assess clinical and radiographic success.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Full pulpotomy, Conventional root canal treatment
- Keywords
- irreversible pulpitis, full pulpotomy, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomyProcedure or surgery
The patients will receive full pulpotomy as follows:
-Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis from all canals, and apply the bioceramic material. The operator will seal the cavity with glass ionomer restoration.
Conventional root canal treatmentProcedure or surgery
The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
| Study group | Role | What they receive |
|---|---|---|
| Root Canal Treatment | Active comparator | The patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3 and 6 months to assess clinical and radiographic success. Receives: Procedure: Conventional root canal treatment |
| Full Pulpotomy | Experimental | The patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3 and 6 months to assess clinical and radiographic success. Receives: Procedure: Full pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Successful Cases
- It will be measured as a percentage.
- It will be decided according to the clinical and radiographic criteria of success and failure.
Measured: After 1, 3, and 6 months
Diagnostic accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
- The Artificial Intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical finding of carious pulp exposure will be used as the gold standard).
- The outcome will be reported as Sensitivity and Specificity.
Measured: On the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayand Amer Mohamed Yehia Amer, Misr International University
- Investigators
- Ahmed A Ghobashy, Prof. Dr., Study director, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597487
- Sponsor's protocol ID
- MIU-IRB-2324-039
- Status last verified
- Jul 2025
- First submitted
- 11 Sep 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Wolters Classification of Pulpitis and the Radiographic Caries Depth Detected Using Artificial Intelligence on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06597487
- Acronym / sponsor ID
- MIU-IRB-2324-039
- Conditions
- Pulpitis - Irreversible
- Keywords
- irreversible pulpitis, full pulpotomy, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 19 Sep 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.
This study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis.
Detailed description
- Patients with mature permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
- The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
- Pre-operative radiographs will be taken, and radiographic caries depth will be assessed.
- An Artificial Intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure. The diagnostic accuracy of the software will be evaluated by comparing its readings with clinical findings of pulp exposure after caries removal.
- The patients will be randomized to receive either full pulpotomy or conventional root canal treatment.
- The patients will be followed up for 1, 3 and 6 months to assess clinical and radiographic success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root Canal Treatment | Active comparator | Procedure: Conventional root canal treatmentThe patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3 and 6 months to assess clinical and radiographic success. |
| Full Pulpotomy | Experimental | Procedure: Full pulpotomyThe patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3 and 6 months to assess clinical and radiographic success. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mature permanent molars with irreversible pulpitis.
- Presence of bleeding pulp tissues from all canals.
- The tooth is not periodontally compromised.
Key exclusion criteria (3 listed)
- Non-vital teeth.
- Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
- Molars with immature roots.
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 pulpotomyThe patients will receive full pulpotomy as follows: -Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis from all canals, and apply the bioceramic material. The operator will seal the cavity with glass ionomer restoration. | Procedure or surgery | Full Pulpotomy |
| Conventional root canal treatmentThe patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis. | Procedure or surgery | Root Canal Treatment |
Primary outcome
Percentage of Successful Cases
Time frame: After 1, 3, and 6 months
* It will be measured as a percentage. * It will be decided according to the clinical and radiographic criteria of success and failure.
Diagnostic accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
Time frame: On the day of the procedure
* The Artificial Intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical finding of carious pulp exposure will be used as the gold standard). * The outcome will be reported as Sensitivity and Specificity.
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 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed A Ghobashy, Prof. Dr. study director
Misr International University
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 and Conventional root canal treatment in people with Pulpitis - Irreversible, 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 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 25 Jul 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 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?
Percentage of Successful Cases (time frame: After 1, 3, and 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 25 Jul 2025.