Clinical and Radiographic Evaluation of Propolis As a Hemostatic Agent for Pulpotomy of Mature Permanent Molars with Irreversible Pulpitis Using Two Different Dressing Materials

Phase 2

Active, not recruiting

• Conditions: Irreversible Pulpitis; Pulpitis; Pulpitis - Irreversible

• Registration Number: NCT06679075
• Lead Sponsor: Misr International University

Brief Summary

The goal of this clinical trial is to assess the effectiveness of propolis as a hemostatic agent in pulpotomy for adult permanent molars, compared to sodium hypochlorite (NaOCl). It also examines how bioceramic putty performs against mineral trioxide aggregate (MTA) in vital pulp therapy for cases of irreversible pulpitis.

Participants will be divided into four groups (15 patients each):

* Propolis + bioceramic putty

* Propolis + MTA

* Sodium hypochlorite + bioceramic putty

* Sodium hypochlorite + MTA The Investigator will record the bleeding time and postoperative pain will be recorded. The researcher will assess the clinical and radiographic outcomes for success at 1, 3, and 6 months.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Participants of both genders falling within the age range of 20 to 45 years.
• Presence of vital mature permanent molars diagnosed as mild or severe irreversible pulpitis per Wolter's classification.
• Confirmation of vital bleeding pulp tissue in all canals following complete pulpotomy.

Exclusion Criteria

• Non-vital teeth.
• Teeth with Immature roots.
• Uncontrolled pulpal bleeding persisting beyond 10 minutes post-application of sodium hypochlorite as a hemostatic agent.
• Insufficient bleeding post-pulp exposure, indicative of pulp degeneration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical and radiographic success rate	1, 3, 6 months	Success rate of full pulpotomy procedure using different hemostatic agents and different dressing materials using the clinical and radiographic criteria for success and failure.
Bleeding time	During hemostasis (0-10 minutes)	Recording the bleeding time of different participants during hemostasis.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	24 hours, 3 days, 1 week	Recording the post-operative pain using Heft-Parker visual analogue scale Minimum value: None Maximum value: Maximum possible The higher values indicate more post-operative pain

Trial Locations

Locations (1)

Misr International University; 🇪🇬 Cairo, Obour, Egypt