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

NCT ID: NCT06679075

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Irreversible Pulpitis Pulpitis Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Full pulpotomy using propolis and bioceramic putty

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

Full pulpotomy using Propolis and MTA

Intervention Type 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

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.

Group Type EXPERIMENTAL

Full pulpotomy using sodium hypochlorite and bioceramic putty

Intervention Type 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 + 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

Group Type ACTIVE_COMPARATOR

Full pulpotomy using sodium hypochlorite and MTA

Intervention Type 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.

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Misr International University

OTHER

Sponsor Role lead

Responsible Party

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Omar Hisham Selim

Master's of Endodontics Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Misr International University

Cairo, Obour, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MIU-IRB-2324-047

Identifier Type: -

Identifier Source: org_study_id

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