Clinical and Radiographic Evaluation of Propolis as a Hemostatic Agent in Full Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis

August 7, 2026 updated by: Omar Hisham Selim, Misr International University

Clinical and Radiographic Evaluation of Propolis as a Hemostatic Agent in Full Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis Using Two Different Dressing Materials: A Randomized Clinical Trial

The goal of this randomized clinical trial is to assess the effectiveness of propolis as a hemostatic agent in full pulpotomy for mature permanent molars with irreversible pulpitis, compared to sodium hypochlorite (NaOCl). The study also compares how bioceramic putty performs compared to mineral trioxide aggregate (MTA) as pulpotomy dressing materials.

Participants will be randomly allocated into four groups (15 patients each) according to the hemostatic agent and dressing material used:

  • Propolis + bioceramic putty
  • Propolis + MTA
  • Sodium hypochlorite + bioceramic putty
  • Sodium hypochlorite + MTA Bleeding time and postoperative pain will be recorded. Clinical and radiographic success will be evaluated at 1, 3, and 6 months following treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 irreversible pulpitis.
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
1, 3, 6 months
Bleeding time
Time Frame: During hemostasis (0-10 minutes)
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
Time Frame: 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
24 hours, 3 days, 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

March 16, 2026

Study Completion (Actual)

March 16, 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 (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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