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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Symptomatic Irreversible Pulpitis (SIP)

Treatments: Procedure: Regenerative pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07196683

New ENDO 5-5-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Ascorbic acid augmented PRF scaffold

Experimental group

Treatment:

Procedure: Regenerative pulpotomy

Tannic acid cross linked PRF scaffold

Experimental group

Treatment:

Procedure: Regenerative pulpotomy

PRF scaffold

Active Comparator group

Treatment:

Procedure: Regenerative pulpotomy