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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical and radiographic success rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Full pulpotomy using propolis and bioceramic putty (Procedure)
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.
Intervention: Full pulpotomy using Propolis and MTA (Procedure)
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.
Intervention: Full pulpotomy using sodium hypochlorite and bioceramic putty (Procedure)
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
Intervention: Full pulpotomy using sodium hypochlorite and MTA (Procedure)
Outcomes
Primary Outcomes
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.
Bleeding time
Time Frame: During hemostasis (0-10 minutes)
Recording the bleeding time of different participants during hemostasis.
Secondary Outcomes
- Post-operative pain(24 hours, 3 days, 1 week)
Investigators
Omar Hisham Selim
Master's Candidate in Endodontics
Misr International University