Skip to content

Regenerative Potentials of Mature Mandibular Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds

Regenerative Potentials of Mature Mandibular First Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07196683
Enrollment
36
Registered
2025-09-29
Start date
2026-07-01
Completion date
2027-11-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Keywords

pulpotomy, regenerative pulpotomy, ascorbic acid-augmented PRF, tannic acid crosslinked-PRF

Brief 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

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.

Interventions

PROCEDURERegenerative pulpotomy

Regenerative pulpotomy combines the use of hydraulic calcium silicate based cements; MTA, together with biodegradable scaffolds such as PRF.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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: * 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Intensity of postoperative pain6, 12, 24, and 72 hours postoperativelymeasured using numerical rating scale

Secondary

MeasureTime frameDescription
Overall success rate1, 3, 6, 9 and 12 months postoperatively.Based on clinical and radiographic signs and symptoms
IL-8 and TNF-α levels in pulpal bloodUpon access cavity preparation

Countries

Egypt

Contacts

CONTACTOmnia A Hakim, Assistant lecturer
Omnia.mohamed@dentistry.cu.edu.eg+201023636291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026