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

NCT ID: NCT06828978

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chitosan Hydrogel after full pulpotomy

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.

Group Type: EXPERIMENTAL

Full Pulpotomy

Intervention Type: 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.

Platelet Rich Fibrin after full pulpotomy

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.

Group Type: ACTIVE_COMPARATOR

Full Pulpotomy

Intervention Type: 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.

Interventions

Full Pulpotomy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Perihan Adel Abdel Aziz Wafi

Resident at Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Perihan A Wafi, Bds

Role: CONTACT

perihan.adel@dentistry.cu.edu.eg

01006150247 ext. 002

Other Identifiers

ENDO9-1-2

Identifier Type: -

Identifier Source: org_study_id