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The aim of this study is to compare two biomaterials used for retrograde obturation during apical surgery. This surgery is indicated in healthy patients when root canal treatment (endodontics) has failed to eliminate a periapical lesion (a persistent infection in the root of the tooth).
The main question it seeks to answer is:
- Is TotalFill® BC-RRM Fast Set Putty more effective than ProRoot® MTA in periapical surgery in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two materials applied as part of the standard surgical procedure. Subsequently, clinical and radiographic follow-up will be performed to assess the degree of healing of the periapical lesion with a 1-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTA (Mineral Trioxide Aggregate) | Active Comparator | Patients undergoing apical surgery treated with retrograde obturation using Mineral Trioxide Aggregate (MTA). |
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| BioCeramic Root Repair Material Fast Set Putty (BCRRM) | Experimental | Patients undergoing apical surgery treated with retrograde obturation using BioCeramic Root Repair Material Fast Set Putty (BCRRM). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mineral Trioxide Aggregate | Device | Trioxide Mineral Aggregate as a retrograde filling material has 3 basic properties: biocompatibility, impermeable sealing of the root canal and properties that facilitate its clinical use. It has excellent properties that contribute to the healing of the periapical lesion. |
| Measure | Description | Time Frame |
|---|---|---|
| Periapical lesion healing assessed by CBCT using 3D PENN criteria. | Periapical healing will be evaluated using cone-beam computed tomography (CBCT) at 12 months after periapical surgery. Lesion volume or dimensions will be measured and the percentage of reduction will be calculated. Based on these measurements, healing will be classified according to the 3D PENN CBCT criteria into complete, limited, uncertain, or unsatisfactory healing. A comparison will be made between ProRoot® MTA versus TotalFill® BC-RRM Fast Set Putty as retrograde filling materials. | 12 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Valencia | Valencia | 46010 | Spain |
Considerations about sharing individual participant data are ongoing. Any future data sharing will adhere to all institutional policies to ensure participant confidentiality.
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| BioCeramic Root Repair Material Fast Set Putty. | Device | BioCeramic Root Repair Material (BCRRM) is a pre-mixed, easy to handle material that has demonstrated properties equivalent to MTA in terms of periapical lesion healing. |
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