Phase 4
N=64
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Pulpitis - Irreversible
Bottom Line
View on ClinicalTrials.gov: NCT05853185 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Clinical Success at 6 Months — 27; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pro Root MTA® (Drug); EBRRM® (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Liaquat University of Medical & Health Sciences
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success at 6 Months |
27; 30 | — |
| SECONDARY Radiographic Success |
30; 32 | — |
Summary
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.
Eligibility Criteria
Inclusion Criteria
- Patients with diagnosis of irreversible pulpitis without apical periodontitis
- Either gender
- Lower Age 10 Years - Upper Age 40 Years
Exclusion Criteria
- Teeth displaying indications of resorption.
- Teeth that have not fully developed, characterized by open apices.
- Canals that are calcified or obstructed.
- Perforations that were caused by the dentist.
- Fractures in the root
- Teeth that cannot be restored
- • Teeth that are unable to withstand frigid temperatures, have a sinus infection, or have swelling around them.
- There has been no pulp exposure despite the removal of carious lesion.
- Ten minutes after a pulpotomy, hemorrhage could not be stopped.
- Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
Data sourced from ClinicalTrials.gov (NCT05853185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.