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NCT Number: NCT06828978

Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars

The aim of this study is to assess the clinical and radiographic success and postoperative pain in mature mandibular molars following vital pulp therapy using chitosan hydrogel versus platelet rich fibrin.

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Key information

Conditions

Regenerative Pulpotomy for Symptomatic Pulpitis of Mandibular Permanent Molars With Mature Apices

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients suffering from Symptomatic pulpitis in mature mandibular molars only will be involved.
  • Tooth should give positive response to cold test
  • Haemostasis should be achieved after full pulpotomy
  • The tooth is restorable and free from advanced periodontal disease, cracks and splits.
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow-up period.
  • Patients with mature root apices
  • Patients with no internal or external resorption and no periapical lesions
  • Soft tissues around the tooth are normal with no swelling or sinus tract

Exclusion criteria

  • Patients with immature roots.
  • Haemostasias after 10 minutes cannot be controlled after full pulpotomy Patients with any systemic disease that may affect normal healing.
  • Patients with periapical lesions or infections.
  • Pregnant females.
  • Patients who could/would not participate in a 6 months follow-up.
  • Patients with fistula or swelling
  • Patients with necrotic pulp.
  • Patients with old age.

Treatment and study plan

Full Pulpotomy

Procedure

After control of bleeding in teeth allocated to the intervention group, the gel is to be placed into the pulp chamber to a level 3 mm below the cementoenamel junction (CEJ) over the root pulp stumps.

Primary outcomes

  1. Success Rate

    Time frame: 6 months (Postoperative)

    Using Radiographic success criteria by periapical index (Orstavik et al., 1986)

Secondary outcomes

  1. Postoperative pain

    Time frame: 1st day up to 7th day

    Using Modified Visual Analogue Scale for pain with a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable

  2. Tooth sensibility

    Time frame: 1,3,6 months (postoperative)

    Using Electric pulp test

Study contacts

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

Perihan A Wafi, Bds

CONTACT

[email protected]

01006150247 ext. 002

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

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.