Outcome of Endodontic Retreatment in One or Two Visits

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 and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. The aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.

Official Title
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Clinical and Radiographic Outcome of Endodontic Retreatment in One or Two Visits: A Randomized Controlled Trial.

Conditions
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Endodontic Disease, Endodontically Treated Teeth, Root Canal Infection

Intervention / Treatment
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* Procedure: Non-surgical root canal retreatment


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. Retreatment cases due to an endodontic failure. Diagnosis of apical periodontitis. 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 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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No

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 |
| --- | --- |
| Active Comparator: 1-vist endodontic retreatment<br>Non-surgical root canal retreatment performed in one visit | Procedure: Non-surgical root canal retreatment<br>* Non-surgical root canal retreatment<br>|
| Active Comparator: 2-vist endodontic retreatment<br>Non-surgical root canal retreatment performed in two visits | Procedure: Non-surgical root canal retreatment<br>* Non-surgical root canal retreatment<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 (0-10) of patient' level of pain, from no pain to extreme pain | Immediately post treatment | 
| Clinical post-operative pain | VAS score (0-10) of patient' level of pain, from no pain to extreme pain | 4 hours post-treatment | 
| Clinical post-operative pain | VAS score (0-10) of patient' level of pain, from no pain to extreme pain | 24 hours post treatment | 
| Clinical post-operative pain | VAS score (0-10) of patient' level of pain, from no pain to extreme pain | 48 hours post treatment | 
| Clinical signs or symptoms of periapical disease 1 | Absence/presence of clinical signs or symptoms of periapical disease | 1 year | 
| Clinical signs or symptoms of periapical disease 2 | Absence/presence of clinical signs or symptoms of periapical disease | 2 years | 
| Clinical signs or symptoms of periapical disease 4 | Absence/presence of clinical signs or symptoms of periapical disease | 4 years | 
| Clinical signs or symptoms of periapical disease 6 | Absence/presence of clinical signs or symptoms of periapical disease | 6 years | 
| Clinical signs or symptoms of periapical disease 10 | Absence/presence of clinical signs or symptoms of periapical disease | 10 years | 
| Radiographic periapical absence/presence of radiographic apical periodontitis | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 1 year | 
| Radiographic periapical absence/presence/changes in radiographic apical periodontitis | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 2 years | 
| Radiographic periapical absence/presence/changes in radiographic apical periodontitis | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 4 years | 
| Radiographic periapical absence/presence/changes in radiographic apical periodontitis | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 6 years | 
| Radiographic periapical absence/presence/changes in radiographic apical periodontitis | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1 | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease | 1 year | 
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2 | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease | 2 years | 
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4 | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease | 4 years | 
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6 | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease | 6 years | 
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10 | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease | 10 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, Periapical healing, Outcome