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Preservation of pulp vitality through vital pulp therapy (VPT) has emerged in contemporary endodontics, particularly for immature permanent teeth. In cases of irreversible pulpitis, recent literature suggests that clinical symptoms do not always correlate with histopathological findings, supporting the use of conservative approaches such as full pulpotomy. This is especially relevant in young patients where continued root development and apical closure are critical for long-term tooth integrity and functionality. Immature teeth, due to their high cellularity and vascularity, exhibit a greater regenerative capacity, making them indicated for biologically based treatments.
Among the materials used for VPT, calcium silicate-based cements (CSCs) have demonstrated good biological and physicochemical properties, including high biocompatibility, antimicrobial effects, alkaline pH, and sustained release of calcium ions that stimulate biomineralization. Mineral Trioxide Aggregate (MTA) has long been considered the gold standard; however, it is associated with several clinical limitations such as extended setting time, complex handling, and potential tooth discoloration. To address these drawbacks, newer generation premixed bioceramics have been introduced. These include NeoPUTTY®, Total Fill® BC UNIVERSAL RRM™, and Bio-C® Repair, each exhibiting unique compositional and functional properties designed to enhance clinical performance and ease of use.
Despite promising individual results, no clinical study has yet compared these three materials within the context of pulpotomy in immature permanent molars with irreversible pulpitis. This randomized clinical trial aims to fill this gap by evaluating their clinical and radiographic outcomes over a 12-month period, to better guide material selection in vital pulp therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo PUTTY (Nusmile Inc, Houston, TX; USA) | Experimental | premixed bioactive bioceramic composed of an inorganic powder containing tricalcium and dicalcium silicate in a water-free organic liquid. |
|
| Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) | Active Comparator | premixed bioceramic material composed of calcium aluminosilicate paste designed for permanent root canal repair and surgical applications. |
|
| Bio-C® Repair (BCR; Angelus, Londrina, Brazil) | Active Comparator | new ready-to-use bioceramic repair material. Bio-C has indications similar to MTA and is composed of calcium silicates [tricalcium silicate, dicalcium silicate], tricalcium aluminate, calcium oxide (for the release of calcium ions), and zirconium oxide as a radioopacifier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-C® Repair (BCR; Angelus, Londrina, Brazil) | Device | To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development. |
| Measure | Description | Time Frame |
|---|---|---|
| -Root formation and apical closure. | Continued root formation and apical closure will be assessed using standardized periapical radiographs of the treated immature permanent molars and classified according to Cvek's stages of root development. Radiographic evaluation will be performed by a calibrated examiner. Progression in root development will be determined by changes in root length and apical foramen morphology compared with baseline. Cvek's classification includes five radiographic stages of root development: Stage I (A): < 1/2 root length Stage II (B): 1/2 root length Stage III (C): 2/3 root length Stage IV (D): Nearly complete root length with wide open apical foramen Stage V (E): Complete root development with closed apical foramen | 12 months |
| -Postoperative pain. -Percussion and/or palpation pain. | Pain response will be recorded as a binary outcome (Yes/No) based on the patient's subjective report during standardized clinical examination. The assessment will be performed by a calibrated examiner using gentle vertical percussion and periapical palpation according to routine endodontic diagnostic procedures. Measurement Tool Clinical percussion test Clinical palpation test Patient-reported pain response during examination (verbal report) Postoperative pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable), recorded by the patient. | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| -Presence of periapical lesion. | Presence of periapical lesion assessed on standardized periapical radiographs using the Periapical Index (PAI); lesions defined as a PAI score ≥ 3. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite Saint Joseph de Beyrouth | Beirut | Lebanon |
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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 | Jan 9, 2026 |
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| Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) | Device | To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development. |
|
| Neo PUTTY (Nusmile Inc, Houston, TX; USA) | Device | To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development. |
|
| Jan 9, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019934 | International Normalized Ratio |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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