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Completed

NCT Number: NCT05853185

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

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

10 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liaquat University of Medical and Health Sciences

Jāmshoro, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pro Root MTA®

Drug

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

EBRRM®

Drug

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

Primary outcomes

  1. Clinical Success at 6 Months

    Time frame: 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 outcomes

  1. Radiographic Success

    Time frame: 6 Months

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

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Registry information

Acronym: GCP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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