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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 selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond â„¢Plus, BioDentineâ„¢, and Theracalâ„¢ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VitreBond LC | Experimental | VitreBond LC used as a liner after selective carious tissue removal. |
|
| Biodentine | Experimental | Biodentine used as a liner after selective carious tissue removal. |
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| Theracal | Experimental | Theracal used as a liner after selective carious tissue removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carious tissue selective removal | Procedure | Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration |
| 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 | 8 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 pulp or periapical disease | Absence/presence of clinical signs or symptoms of pulp or periapical disease | 1 year |
| Clinical signs or symptoms of pulp or periapical disease | Absence/presence of clinical signs or symptoms of pulp or periapical disease | 2 years |
| Clinical signs or symptoms of pulp or periapical disease | Absence/presence of clinical signs or symptoms of pulp or periapical disease | 5 years |
| Radiographic signs of periapical disease |
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Inclusion Criteria:
Exclusion Criteria:
General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain
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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 |
|---|---|
| D003731 | Dental Caries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D011183 | Postoperative Complications |
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Absence/presence of radiographic apical periodontitis
| 1 year |
| Radiographic signs of periapical disease | Absence/presence of radiographic apical periodontitis | 2 years |
| Radiographic signs of periapical disease | Absence/presence of radiographic apical periodontitis | 4 years |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |