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

Pulpitis - Irreversible Clinical Trial

— GCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05853185
• Other study ID #: LUMHS/REC/-93
• Status: Completed
• Phase: Phase 4
• Start date: October 12, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• Pro Root MTA®
Patients in this group will receive the pulpotomy with Pro Root MTA®.
• EBRRM®
Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.

Locations

Country	Name	City	State
Pakistan	Liaquat University of Medical and Health Sciences	Jamshoro	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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