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

Primary Purpose

Pulpitis - Irreversible

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Pro Root MTA®
EBRRM®
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Liaquat University of Medical and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pro Root MTA®

EBRRM®

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Radiographic Success
Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph

Full Information

First Posted
March 25, 2023
Last Updated
August 22, 2023
Sponsor
Liaquat University of Medical & Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05853185
Brief Title
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Acronym
GCP
Official Title
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pro Root MTA®
Arm Type
Experimental
Arm Description
Patients in this group will receive the pulpotomy with Pro Root MTA®.
Arm Title
EBRRM®
Arm Type
Active Comparator
Arm Description
Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.
Intervention Type
Drug
Intervention Name(s)
Pro Root MTA®
Intervention Description
Patients in this group will receive the pulpotomy with Pro Root MTA®.
Intervention Type
Drug
Intervention Name(s)
EBRRM®
Intervention Description
Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Primary Outcome Measure Information:
Title
Clinical Success at 6 Months
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Radiographic Success
Description
Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarang Suresh
Organizational Affiliation
Liaquat University of Medical and Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liaquat University of Medical and Health Sciences
City
Jāmshoro
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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