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This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.
In this study, patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Root canal treatment (RCT) | Active Comparator | For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols |
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| Pulpotomy | Experimental | Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RCT | Procedure | This is the standard of care for this diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a successful outcome of pulpotomy versus RCT | A composite of clinical and radiographic findings and incidence of follow up procedures | From baseline through 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy | Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of pulpotomy | From baseline to two years |
| Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheila Turner, DDS | Contact | (205) 934-5045 | jordan@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashraf Fouad, DDS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D003759 | Dental Implantation, Endosseous, Endodontic |
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| Pulpotomy | Procedure | For cases with normal apical tissues, pulpotomy using tricalcium silicates has been shown to have high clinical success. Either partial or complete pulpotomy will be performed depending on the size of pulp exposure. |
|
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Protein analysis at the time of treatment will be correlated with the outcome of pulpotomy |
| From baseline to 2 years |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D004708 | Endodontics |
| D003813 | Dentistry |
| D011476 | Prosthodontics |