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NCT Number: NCT06679075

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Irreversible Pulpitis Dental Pulp Diseases Pulpitis Pulpitis - Irreversible Stomatognathic Diseases Tooth Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Misr International University

Cairo, Obour, 23726, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

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.

Primary outcomes

  1. 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.

  2. Bleeding time

    Time frame: During hemostasis (0-10 minutes)

    Recording the bleeding time of different participants during hemostasis.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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