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

NCT07196683 | Not Yet Recruiting DMC

• 1 other identifier: New ENDO 5-5-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intensity of postoperative pain

  measured using numerical rating scale

  6, 12, 24, and 72 hours postoperatively

Secondary Outcomes (2)

• Overall success rate

  1, 3, 6, 9 and 12 months postoperatively.

• IL-8 and TNF-α levels in pulpal blood

  Upon access cavity preparation

Study Arms (3)

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

Interventions

Regenerative pulpotomy PROCEDURE

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

Also known as: Vital pulp therapy, PRF pulpotomy

Ascorbic acid augmented PRF scaffold; PRF scaffold; Tannic acid cross linked PRF scaffold

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Central Study Contacts

Omnia A Hakim, Assistant lecturer

CONTACT

+201023636291; Omnia.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

EG (1)