Symptomatic Irreversible Pulpitis (SIP)NCT07196683
Regenerative Potentials of Mature Mandibular Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds
A study testing Regenerative pulpotomy in people with Symptomatic Irreversible Pulpitis (SIP), run by Cairo University at 1 site in Egypt.
Trial summary
The current study aims to assess the influence of different scaffolds on postoperative pain and success rate of pulpotomy in mandibular mature molars with symptomatic irreversible pulpitis Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Regenerative pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Nov 2027
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA I patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 15-40 years.
- Males \& Females.
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent (Appendix I).
- Mature mandibular fist molars:
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- Diagnosed clinically with symptomatic irreversible pulpitis and normal periapical tissue.
- Giving a positive response to pulp sensitivity testing.
- Having negative response to percussion.
- Having normal radiographic appearance of periapical tissues.
- Having bright red color of pulp tissue, with hemorrhage control within 10 mins, upon access cavity preparation.
Who cannot join
- Pregnant and lactating females.
- Patients with physical or mental handicapping conditions.
- Patients unwilling to participate in a 12-months follow up.
- Mandibular first molars with:
- Immature roots.
- Negative response to pulp sensitivity testing.
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- Positive response to percussion.
- Radiographic evidence of periapical lesions, external or internal root resorption, vertical root fracture, or calcification.
- Intraoral swelling or fistula.
- Lack of pulpal bleeding, or inability to achieve hemostasis of the bleeding pulp within 10 mins, upon access cavity preparation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Regenerative Potentials of Mature Mandibular First Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds: A Randomized Controlled Trial
The current study aims to assess the influence of different scaffolds on postoperative pain and success rate of pulpotomy in mandibular mature molars with symptomatic irreversible pulpitis
Read the detailed description
The study aims to assess different scaffolds used in regenerative pulpotomy of mature permanent mandibular first molars diagnosed with symptomatic irreversible pulpitis and their influence on postoperative pain and clinical and radiographic success rate of pulpotomy. It also aims to correlate the level of inflammatory mediators in pulpal blood to the success rate of pulpotomy.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Regenerative pulpotomy
- Keywords
- pulpotomy, regenerative pulpotomy, ascorbic acid-augmented PRF, tannic acid crosslinked-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative pulpotomyProcedure or surgery
Also called Vital pulp therapy, PRF pulpotomy
Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid augmented PRF scaffold | Experimental | Not described Receives: Procedure: Regenerative pulpotomy |
| Tannic acid cross linked PRF scaffold | Experimental | Not described Receives: Procedure: Regenerative pulpotomy |
| PRF scaffold | Active comparator | Not described Receives: Procedure: Regenerative pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
measured using numerical rating scale
Measured: 6, 12, 24, and 72 hours postoperatively
Secondary outcomes (2)
Overall success rate
Based on clinical and radiographic signs and symptoms
Measured: 1, 3, 6, 9 and 12 months postoperatively.
IL-8 and TNF-α levels in pulpal blood
Measured: Upon access cavity preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Abdel Hakim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196683
- Sponsor's protocol ID
- New ENDO 5-5-1
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Potentials of Mature Mandibular First Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07196683
- Acronym / sponsor ID
- New ENDO 5-5-1
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Keywords
- pulpotomy, regenerative pulpotomy, ascorbic acid-augmented PRF, tannic acid crosslinked-PRF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 Sep 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 current study aims to assess the influence of different scaffolds on postoperative pain and success rate of pulpotomy in mandibular mature molars with symptomatic irreversible pulpitis
Detailed description
The study aims to assess different scaffolds used in regenerative pulpotomy of mature permanent mandibular first molars diagnosed with symptomatic irreversible pulpitis and their influence on postoperative pain and clinical and radiographic success rate of pulpotomy. It also aims to correlate the level of inflammatory mediators in pulpal blood to the success rate of pulpotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid augmented PRF scaffold | Experimental | Procedure: Regenerative pulpotomy |
| Tannic acid cross linked PRF scaffold | Experimental | Procedure: Regenerative pulpotomy |
| PRF scaffold | Active comparator | Procedure: Regenerative pulpotomy |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- ASA I patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 15-40 years.
- Males \& Females.
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent (Appendix I).
Key exclusion criteria (10 listed)
- Pregnant and lactating females.
- Patients with physical or mental handicapping conditions.
- Patients unwilling to participate in a 12-months follow up.
- Mandibular first molars with:
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 |
|---|---|---|
| Regenerative pulpotomyAlso: Vital pulp therapy, PRF pulpotomyRegenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF. | Procedure or surgery | Ascorbic acid augmented PRF scaffold, PRF scaffold, Tannic acid cross linked PRF scaffold |
Primary outcome
Intensity of postoperative pain
Time frame: 6, 12, 24, and 72 hours postoperatively
measured using numerical rating scale
2 secondary outcomes
Overall success rate
Time frame: 1, 3, 6, 9 and 12 months postoperatively.
IL-8 and TNF-α levels in pulpal blood
Time frame: Upon access cavity preparation
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 27 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative pulpotomy in people with Symptomatic Irreversible Pulpitis (SIP), run by Cairo 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 11 inclusion and 10 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 27 Mar 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?
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 Omnia A Hakim, Assistant lecturer (+201023636291, Omnia.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of postoperative pain (time frame: 6, 12, 24, and 72 hours postoperatively). 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 27 Mar 2026.