Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.

NCT ID: NCT05853185

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-08-30

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.

Conditions

Pulpitis - Irreversible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pro Root MTA®

Patients in this group will receive the pulpotomy with Pro Root MTA®.

Group Type: EXPERIMENTAL

Pro Root MTA®

Intervention Type: DRUG

Patients in this group will receive the pulpotomy with Pro Root MTA®.

EBRRM®

Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.

Group Type: ACTIVE_COMPARATOR

EBRRM®

Intervention Type: DRUG

Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.

Interventions

Pro Root MTA®

Patients in this group will receive the pulpotomy with Pro Root MTA®.

Intervention Type: DRUG

EBRRM®

Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Sarang Suresh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarang Suresh

Role: PRINCIPAL_INVESTIGATOR

Liaquat University of Medical and Health Science

Locations

Liaquat University of Medical and Health Sciences

Jāmshoro, Sindh, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

LUMHS/REC/-93

Identifier Type: -

Identifier Source: org_study_id