Pulpitis - Irreversible
Conditions
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.
Interventions
DRUGPro Root MTA®
Patients in this group will receive the pulpotomy with Pro Root MTA®.
DRUGEBRRM®
Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Sponsors
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Success | 6 Months | Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph |
Countries
Pakistan
Participant flow
Recruitment details
Department of Operative Dentistry & Endodontics, Liaquat University of Medical and Health Sciences, Jamshoro
Pre-assignment details
All participants fulfilling the inclusion criteria consented for the study.
Participants by arm
| Arm | Count |
|---|---|
| Pro Root MTA® Patients in this group will receive the pulpotomy with Pro Root MTA®.
Pro Root MTA®: Patients in this group will receive the pulpotomy with Pro Root MTA®. | 32 |
| EBRRM® Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.
EBRRM®: Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®. | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | EBRRM® | Total | Pro Root MTA® |
|---|---|---|---|
| Age, Continuous | 31.25 Years STANDARD_DEVIATION 11.322 | 30.72 Years STANDARD_DEVIATION 10.868 | 30.19 Years STANDARD_DEVIATION 10.548 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Pakistan | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Female | 9 Participants | 25 Participants | 16 Participants |
| Sex: Female, Male Male | 23 Participants | 39 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
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.
Time frame: 6 Months
Population: Clinical Outcome Success at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pro Root MTA® | Clinical Success at 6 Months | 27 Participants |
| EBRRM® | Clinical Success at 6 Months | 30 Participants |
Secondary
Radiographic Success
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
Population: Patients with no radiographic findings at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pro Root MTA® | Radiographic Success | 30 Participants |
| EBRRM® | Radiographic Success | 32 Participants |