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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulpitis; Irreversible Pulpitis; Pulpitis - Irreversible
• Intervention / Treatment: Procedure: Full pulpotomy using propolis and bioceramic putty; Procedure: Full pulpotomy using Propolis and MTA; Procedure: Full pulpotomy using sodium hypochlorite and bioceramic putty; Procedure: Full pulpotomy using sodium hypochlorite and MTA

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Obour
    • Cairo, Obour, Egypt, 23726
      • Misr International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propolis + Bioceramic putty; Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and bioceramic putty as a dressing material.	Procedure: Full pulpotomy using propolis and bioceramic putty; Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and bioceramic putty as a dressing material
Experimental: Propolis + MTA; Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and MTA as a dressing material.	Procedure: Full pulpotomy using Propolis and MTA; Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and MTA as a dressing material
Experimental: Sodium hypochlorite + bioceramic putty; Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material.	Procedure: Full pulpotomy using sodium hypochlorite and bioceramic putty; Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material
Active Comparator: Sodium hypochlorite + MTA; Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material	Procedure: Full pulpotomy using sodium hypochlorite and MTA; Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	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	24 hours, 3 days, 1 week

Collaborators and Investigators

• Sponsor: Misr International University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Hemostasis; Propolis; MTA; Irreversible Pulpitis; Pulpotomy; Mineral Trioxide Aggregate; Bioceramic; Vital Pulp Therapy; Full Pulpotomy; Adult Pulpotomy; Hemostatic Agent; Moderate Pulpitis; Severe Pulpitis; Mature Permanent Molars
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis; Anti-Infective Agents; Disinfectants; Propolis; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: MIU-IRB-2324-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No