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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06679075
Enrollment
60
Registered
2024-11-07
Start date
2024-11-01
Completion date
2026-03-16
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

Pulpotomy, Vital Pulp Therapy, Irreversible Pulpitis, Hemostasis, Hemostatic Agent, Propolis, MTA, Bioceramic, Full Pulpotomy, Mineral Trioxide Aggregate, Mature Permanent Molars

Brief summary

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.

Interventions

PROCEDUREFull 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

PROCEDUREFull 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

PROCEDUREFull 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

PROCEDUREFull 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.

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical and radiographic success rate1, 3, 6 monthsSuccess rate of full pulpotomy procedure using different hemostatic agents and different dressing materials using the clinical and radiographic criteria for success and failure.
Bleeding timeDuring hemostasis (0-10 minutes)Recording the bleeding time of different participants during hemostasis.

Secondary

MeasureTime frameDescription
Post-operative pain24 hours, 3 days, 1 weekRecording 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026