Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

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 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.

Official Title
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The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study

Conditions
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Endodontic Disease, Endodontically Treated Teeth

Intervention / Treatment
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* Other: BioRoot RCS® root canal sealer
* Other: AH Plus® root canal sealer


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 irreversible pulpitis or apical symptomatic / asymptomatic periodontitis. Retreatment cases due to an endodontic failure. Single or bi-radicular teeth. Exclusion Criteria: General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities. Specific: root resorption, root fractures, impossibility of restoration and cases were primary or secondary root canal treatment is not the treatment of choice.

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: Primary root canal treatment<br>Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers | Other: BioRoot RCS® root canal sealer<br>* Root canal obturation with guttapercha and BioRoot RCS® root canal sealer<br>Other: AH Plus® root canal sealer<br>* Root canal obturation with guttapercha and AH Plus® root canal sealer<br>|
| Experimental: Secondary root canal treatment<br>Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers | Other: BioRoot RCS® root canal sealer<br>* Root canal obturation with guttapercha and BioRoot RCS® root canal sealer<br>Other: AH Plus® root canal sealer<br>* Root canal obturation with guttapercha and AH Plus® root canal sealer<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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary root canal treatment, Secondary root canal treatment, Outcome, Root canal sealer