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

Not Applicable

Not yet recruiting

• Conditions: Symptomatic Irreversible Pulpitis (SIP)

• Registration Number: NCT07196683
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2025-11-01
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intensity of postoperative pain	6, 12, 24, and 72 hours postoperatively	measured using numerical rating scale

Secondary Outcome Measures

Name	Time	Method
IL-8 and TNF-α levels in pulpal blood	Upon access cavity preparation
Overall success rate	1, 3, 6, 9 and 12 months postoperatively.	Based on clinical and radiographic signs and symptoms

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt