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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Regenerative Pulpotomy for Symptomatic Pulpitis of Mandibular Permanent Molars With Mature Apices
• Intervention / Treatment: Procedure: Full Pulpotomy

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perihan A Wafi, Bds; Phone Number: 002 01006150247; Email: perihan.adel@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	Using Radiographic success criteria by periapical index (Orstavik et al., 1986)	6 months (Postoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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	1st day up to 7th day
Tooth sensibility	Using Electric pulp test	1,3,6 months (postoperative)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis
• Other Study ID Numbers: ENDO9-1-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No