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

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Drug: Pro Root MTA®; Drug: EBRRM®

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Jāmshoro, Sindh, Pakistan
      • Liaquat University of Medical and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pro Root MTA®; Patients in this group will receive the pulpotomy with Pro Root MTA®.	Drug: Pro Root MTA®; Patients in this group will receive the pulpotomy with Pro Root MTA®.
Active Comparator: EBRRM®; Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.	Drug: EBRRM®; Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success at 6 Months	Number of participants with clinical success based on following criteria; No complaints of pain or discomfort outside of the initial two days following therapy.; The tooth shows no signs of pain upon palpation or percussion.; A probing pocket depth of less than 4 mm and 1 mm are indicative of normal movement.; No inflammation or sinus tract can be seen in the soft tissues around the teeth.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Success	Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph	6 Months

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Investigators: Principal Investigator: Sarang Suresh, Liaquat University of Medical and Health Science

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: March 25, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: LUMHS/REC/-93

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes