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

Cairo University (CU)

Status: Not yet enrolling

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

Treatments: Procedure: Full Pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06828978

ENDO9-1-2

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Chitosan Hydrogel after full pulpotomy

Experimental group

Description:

Chitosan used as a medicament for pulpotomy as it is non-toxic biocompatible, bioadhesive, biodegradable, has wound healing ability and possesses antimicrobial activity. In addition, it encourages the odontogenic development of dental pulp stem cells.

Treatment:

Procedure: Full Pulpotomy

Platelet Rich Fibrin after full pulpotomy

Active Comparator group

Description:

Platelet-rich fibrin (PRF) is strictly autologous, biocompatible and kind toward pulp, and hence elicits minimal or nil inflammatory response when placed directly over the severed pulp.

Treatment:

Procedure: Full Pulpotomy