NCT05853185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

March 25, 2023

Results QC Date

June 1, 2023

Last Update Submit

August 22, 2023

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Radiographic Success

    6 Months

Study Arms (2)

Pro Root MTA®

EXPERIMENTAL

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

Drug: Pro Root MTA®

EBRRM®

ACTIVE COMPARATOR

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

Drug: EBRRM®

Interventions

Pro Root MTA®DRUG

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

Pro Root MTA®
EBRRM®DRUG

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

EBRRM®

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with diagnosis of irreversible pulpitis without apical periodontitis
  • Either gender
  • Lower Age 10 Years - Upper Age 40 Years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat University of Medical and Health Sciences

Jāmshoro, Sindh, Pakistan

Location

Results Point of Contact

Title
Dr. Sarang Suresh
Organization
Liaquat University of Medical and Health Sciences
hotchandanisarang@gmail.com
03154044802

Study Officials

  • Sarang Suresh

    Liaquat University of Medical and Health Science

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2023

First Posted

May 10, 2023

Study Start

October 12, 2021

Primary Completion

May 30, 2022

Study Completion

August 30, 2022

Last Updated

August 24, 2023

Results First Posted

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)