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

NCT06828978 | Not Yet Recruiting

• 1 other identifier: ENDO9-1-2
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Success Rate

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

  6 months (Postoperative)

Secondary Outcomes (2)

• Postoperative pain

  1st day up to 7th day

• Tooth sensibility

  1,3,6 months (postoperative)

Study Arms (2)

Chitosan Hydrogel after full pulpotomy

EXPERIMENTAL

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.

Procedure: Full Pulpotomy

Platelet Rich Fibrin after full pulpotomy

ACTIVE COMPARATOR

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.

Procedure: Full Pulpotomy

Interventions

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.

Chitosan Hydrogel after full pulpotomy; Platelet Rich Fibrin after full pulpotomy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Perihan A Wafi, Bds

CONTACT

01006150247; perihan.adel@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Faculty of Dentistry

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: February 17, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02