Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation

Study Overview
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Brief Summary
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The study design is a single-center 2-arm randomized controlled clinical trial. 10 subjects (teeth) requiring a root canal treatment will be enrolled in 2 groups (5 in each group). The aim of the study is to compare the postoperative pain intensity levels in patients with asymptomatic teeth diagnosed for non-surgical orthograde root canal treatment that are disinfected during the root canal treatment procedure by manual irrigation with sodium hypochlorite (NaOCl) solution using an endodontic needle or by a inertial cavitation-generating device.

Official Title
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Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation: A Randomized Controlled Trial

Conditions
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Root Canal Treatment, Post Operative Pain

Intervention / Treatment
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* Other: Conventional irrigation
* Device: Inertial cavitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical status classification system described was used for patients' recruitment. Healthy patients, who were classified by the American Society of Anaesthesiologists (ASA) as ASA I and II Patients with the age of 18 and over Patients who were diagnosed as in need of non-surgical orthograde root canal treatment of an asymptomatic tooth Tooth without signs of previously initiated Root Canal Therapy Exclusion Criteria: Pregnant and lactating females Patients with chronic periodontal diseases Patients with sensitivity or adverse reactions to any medication or materials that were used throughout the treatment procedure Patients with acute periapical periodontitis Patients with acute periodontal abscess Patients who could not abide by the follow-up time Patients who used analgesics 1-week prior or antibiotics 1-month prior to treatment Uncooperative patients Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth) Teeth with poor prognosis, for example, due to deep root caries or big root resorption Teeth with more than/or equal 4 mm periodontal pocket depth Teeth with an inaccessible root end Teeth with apical resorption or a radiologically not clearly defined apex Fractured teeth Teeth with immature or open apices Teeth with root apices extending into the maxillary sinus Teeth with external resorption communicating with the pulp

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional irrigation<br>Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. | Other: Conventional irrigation<br>* The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.<br>|
| Experimental: Inertial cavitation<br>Root canal cleaning will be performed by inertial cavitation-generating device. | Device: Inertial cavitation<br>* The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical postoperative pain | VAS score of patient's level of pain, from no pain to extreme pain | 6 hours | 
| Clinical postoperative pain | VAS score of patient's level of pain, from no pain to extreme pain | 24 hours | 
| Clinical postoperative pain | VAS score of patient's level of pain, from no pain to extreme pain | 48 hours | 
| Clinical postoperative pain | VAS score of patient's level of pain, from no pain to extreme pain | 72 hours | 
| Clinical postoperative pain | VAS score of patient's level of pain, from no pain to extreme pain | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root Canal Irrigation, Root Canal Cleaning, Root Canal Treatment, Post Operative Pain, Root Canal Disinfection, Inertial cavitation, NaOCl Irrigation, Sodium hypochlorite (NaOCl) irrigation