A Phase 4 interventional study of Pro Root MTA® and EBRRM® in Pulpitis - Irreversible, sponsored by Liaquat University of Medical & Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 10 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Liaquat University of Medical & Health Sciences · Phase 4, Interventional, and Treatment
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.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's enrollment of 64 is close to the median of 62 across 275 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Patients in this group will receive the pulpotomy with Pro Root MTA®.
Drug: Pro Root MTA®
Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.
Drug: EBRRM®
Patients in this group will receive the pulpotomy with Pro Root MTA®.
Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
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
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
Department of Operative Dentistry \& Endodontics, Liaquat University of Medical and Health Sciences, Jamshoro
| Milestone | Pro Root MTA® | EBRRM® |
|---|---|---|
| Started | 32 | 32 |
| Completed | 32 | 32 |
| Not completed | 0 | 0 |
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.
| Participants | Pro Root MTA® | EBRRM® |
|---|---|---|
| Clinical Success at 6 Months | 27 | 30 |
Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph
| Participants | Pro Root MTA® | EBRRM® |
|---|---|---|
| Radiographic Success | 30 | 32 |
Collected over 6 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pro Root MTA® | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| EBRRM® | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
Overall 64 Patients were included.
| Age, Continuous(Years) | Pro Root MTA® | EBRRM® | Total |
|---|---|---|---|
| Mean | 30.19 ± 10.548 | 31.25 ± 11.322 | 30.72 ± 10.868 |
| Sex: Female, Male(Participants) | Pro Root MTA® | EBRRM® | Total |
|---|---|---|---|
| Female | 16 | 9 | 25 |
| Male | 16 | 23 | 39 |
| Race and Ethnicity Not Collected(Participants) | Pro Root MTA® | EBRRM® | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Pro Root MTA® | EBRRM® | Total |
|---|---|---|---|
| Pakistan | 32 | 32 | 64 |
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Liaquat University of Medical & Health Sciences