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NCT Number: NCT07196683

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

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

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regenerative pulpotomy

Procedure

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

Other names: Vital pulp therapy, PRF pulpotomy

Primary outcomes

  1. Intensity of postoperative pain

    Time frame: 6, 12, 24, and 72 hours postoperatively

    measured using numerical rating scale

Secondary outcomes

  1. Overall success rate

    Time frame: 1, 3, 6, 9 and 12 months postoperatively.

    Based on clinical and radiographic signs and symptoms

  2. IL-8 and TNF-α levels in pulpal blood

    Time frame: Upon access cavity preparation

Study contacts

Contact information is provided by the study sponsor or research team.

Omnia A Hakim, Assistant lecturer

CONTACT

[email protected]

+201023636291

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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