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

NCT06679075 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: MIU-IRB-2324-047
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis; Pulpitis; Pulpitis - Irreversible

Keywords

Pulpotomy; Vital Pulp Therapy; Adult Pulpotomy; Irreversible Pulpitis; Hemostasis; Hemostatic Agent; Propolis; MTA; Bioceramic; Full Pulpotomy; Mineral Trioxide Aggregate; Moderate Pulpitis; Severe Pulpitis; Mature Permanent Molars

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Post-operative pain

  24 hours, 3 days, 1 week

Study Arms (4)

Propolis + Bioceramic putty

EXPERIMENTAL

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

Propolis + MTA

EXPERIMENTAL

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

Sodium hypochlorite + bioceramic putty

EXPERIMENTAL

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

Sodium hypochlorite + MTA

ACTIVE COMPARATOR

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

Interventions

Full pulpotomy using propolis and bioceramic putty PROCEDURE

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

Propolis + Bioceramic putty

Full pulpotomy using Propolis and MTA PROCEDURE

Full Pulpotomy for participants with mature adult molars diagnosed with irreversible pulpitis; using Propolis as a hemostatic agent and MTA as a dressing material

Propolis + MTA

Full pulpotomy using sodium hypochlorite and bioceramic putty PROCEDURE

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

Sodium hypochlorite + bioceramic putty

Full pulpotomy using sodium hypochlorite and MTA PROCEDURE

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.

Sodium hypochlorite + MTA

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, Obour, 23726, Egypt

Location

MeSH Terms

Conditions

Pulpitis

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's of Endodontics Candidate

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)