Clinical trial NCT05853185: Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Official title: Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulpitis - Irreversible
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.

Eligibility criteria: Inclusion Criteria:

1. Patients with diagnosis of irreversible pulpitis without apical periodontitis
2. Either gender
3. 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.

Primary outcomes:
measure: Clinical Success at 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Radiographic Success
timeFrame: 6 Months
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Liaquat University of Medical and Health Sciences
state: Sindh
Study officials:
affiliation: Liaquat University of Medical and Health Science
name: Sarang Suresh
role: PRINCIPAL_INVESTIGATOR
References: