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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro Root MTA® | Experimental | Patients in this group will receive the pulpotomy with Pro Root MTA®. |
|
| EBRRM® | Active Comparator | Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pro Root MTA® | Drug | Patients in this group will receive the pulpotomy with Pro Root MTA®. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success at 6 Months | Number of participants with clinical success based on following criteria
| 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarang Suresh | Liaquat University of Medical and Health Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaquat University of Medical and Health Sciences | Jāmshoro | Sindh | Pakistan |
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All participants fulfilling the inclusion criteria consented for the study.
Department of Operative Dentistry & Endodontics, Liaquat University of Medical and Health Sciences, Jamshoro
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| ID | Title | Description |
|---|---|---|
| FG000 | 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®. |
| FG001 | 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)®. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overall 64 Patients were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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®. |
| BG001 | EBRRM® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Success at 6 Months | Number of participants with clinical success based on following criteria
| Clinical Outcome Success at 6 months | Posted | Count of Participants | Participants | 6 Months |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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®. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarang Suresh | Liaquat University of Medical and Health Sciences | 03154044802 | hotchandanisarang@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 21, 2023 | Aug 22, 2023 | Prot_SAP_ICF_004.pdf |
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| EBRRM® |
| Drug |
Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (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)®.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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)®. |
|
|
| Secondary | Radiographic Success | Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph | Patients with no radiographic findings at 6 months | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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)®. | 0 | 32 | 0 | 32 | 0 | 32 |
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