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This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary root canal treatment | Experimental | Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers |
|
| Secondary root canal treatment | Experimental | Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioRoot RCS® root canal sealer | Other | Root canal obturation with guttapercha and BioRoot RCS® root canal sealer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical post-operative pain | VAS score of patient' level of pain, from no pain to extreme pain | Immediately post-treatment. |
| Clinical post-operative pain | VAS score of patient' level of pain, from no pain to extreme pain | 4 hours post-treatment |
| Clinical post-operative pain | VAS score of patient' level of pain, from no pain to extreme pain | 24 hours post treatment |
| Clinical post-operative pain | VAS score of patient' level of pain, from no pain to extreme pain | 48 hours post treatment |
| Clinical signs or symptoms of periapical disease | Absence/presence of clinical signs or symptoms of periapical disease | 1 year |
| Clinical signs or symptoms of periapical disease | Absence/presence of clinical signs or symptoms of periapical disease | 2 years |
| Clinical signs or symptoms of periapical disease | Absence/presence of clinical signs or symptoms of periapical disease | 4 years |
| Clinical signs or symptoms of periapical disease | Absence/presence of clinical signs or symptoms of periapical disease |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D019553 | Tooth, Nonvital |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| AH Plus® root canal sealer | Other | Root canal obturation with guttapercha and AH Plus® root canal sealer |
|
| 6 years |
| Radiographic periapical healing | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 1 year |
| Radiographic periapical healing | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 2 years |
| Radiographic periapical healing | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 4 years |
| Radiographic periapical healing | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 6 years |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease |
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease |
| 2 years |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease | 4 years |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease | 6 years |
| Correlation of prognostic factors and radiographic periapical healing | Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to radiographic periapical Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing | 1 year |
| Correlation of prognostic factors and radiographic periapical healing | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing | 2 years |
| Correlation of prognostic factors and radiographic periapical healing | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing | 4 years |
| Correlation of prognostic factors and radiographic periapical healing | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing | 6 years |