Carious Tissue Selective Removal on Permanent Posterior Teeth.

Study Overview
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Brief Summary
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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 ™Plus, BioDentine™, and Theracal™ 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.

Official Title
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Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.

Conditions
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Dental Caries, Dental Materials

Intervention / Treatment
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* Procedure: Carious tissue selective removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form. Understands and is willing to comply with all study procedures and restrictions. Not presence of clinically significant and relevant abnormalities of clinical history or oral examination. Diagnosis of normal pulp or reversible pulpitis. No presence of periapical periodontitis Posterior teeth 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VitreBond LC<br>VitreBond LC used as a liner after selective carious tissue removal. | Procedure: Carious tissue selective removal<br>* Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration<br>|
| Experimental: Biodentine<br>Biodentine used as a liner after selective carious tissue removal. | Procedure: Carious tissue selective removal<br>* Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration<br>|
| Experimental: Theracal<br>Theracal used as a liner after selective carious tissue removal. | Procedure: Carious tissue selective removal<br>* Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Dental materials, Outcome, Postoperative Pain