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

Misr International University

Status and phase: Active, not recruiting; Phase 2

Conditions: Pulpitis; Irreversible Pulpitis; Pulpitis - Irreversible

Treatments: Procedure: Full pulpotomy using sodium hypochlorite and bioceramic putty; Procedure: Full pulpotomy using sodium hypochlorite and MTA; Procedure: Full pulpotomy using Propolis and MTA; Procedure: Full pulpotomy using propolis and bioceramic putty

Study type: Interventional

Funder types: Other

Identifiers

NCT06679075

MIU-IRB-2324-047

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups

Propolis + Bioceramic putty

Experimental group

Description:

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.

Treatment:

Procedure: Full pulpotomy using propolis and bioceramic putty

Propolis + MTA

Experimental group

Description:

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.

Treatment:

Procedure: Full pulpotomy using Propolis and MTA

Sodium hypochlorite + bioceramic putty

Experimental group

Description:

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.

Treatment:

Procedure: Full pulpotomy using sodium hypochlorite and bioceramic putty

Sodium hypochlorite + MTA

Active Comparator group

Description:

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

Treatment:

Procedure: Full pulpotomy using sodium hypochlorite and MTA