Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

Study Overview
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Brief Summary
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This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using different methods of irrigation activation.

Detailed Description
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Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using different methods of irrigation activation. Methodology: In this prospective clinical trial, root-canal treatment was performed on 162 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to one of 3 treatment groups, each of which was treated using a different activation protocol during the final irrigation [manual dynamic irrigation (MDI), passive ultrasonic irrigation (PUI), sonic irrigation (SI)]. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 24h, 48h and 7 days using a modified 4-step visual analogue scale (VAS). Patients were recalled at 12 months for clinical and radiographic examinations. Periodontal healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P < 0.05 considered statistically significant.

Official Title
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Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment in Posterior Teeth With Chronic Apical Periodontitis

Conditions
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Periapical Periodontitis, Root Canal Infection

Intervention / Treatment
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* Procedure: three irrigation activation methods
* Procedure: conventional needle irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a non-contributory medical history must have an asymptomatic, necrotic premolar or molar with periapical lesions of > 2.0 x 2.0 mm around one or both roots must be diagnosed as chronic apical periodontitis Exclusion Criteria: Those with clinical symptoms (acute pain) have periapical radiolucency of >5 mm no previous endodontic treatment no severe periodontal disease in the related tooth non-restorable tooth use of any analgesics within the previous 3 days or antibiotics within the previous month

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: three irrigation activation methods<br>Manual dynamic irrigation was performed using a well-fitting gutta-percha cone inserted to WL with in-and-out vertical strokes of 5 mm at a rate of approximately 100 strokes per minute in order to hydrodynamically displace the irrigant. Passive ultrasonic irrigation was performed using a non-cutting size 25 file attached to a piezoelectric ultrasonic unit. Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm. | Procedure: three irrigation activation methods<br>* passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation<br>* Other names: passive ultrasonic irrigation (Irrisafe; Satelec Acteon, Mérignac, France), sonic irrigation (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), manual dynamic irrigation (Kerr Dental, USA);|
| Active Comparator: Conventional needle irrigation (control)<br>Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute. | Procedure: conventional needle irrigation<br>* conventional needle irrigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline postoperative pain at 1 week | Pain was measured using a modified visual analogue scale (VAS) with 4 levels, as follows: 1, no pain; 2, slight pain (mild discomfort, no treatment needed); 3, moderate pain (pain required analgesics for relief); 4, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit). Patients were provided forms and asked to record preoperative pain as well as pain at 24 hours, 48 hours and 1 week postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits. | 24 hours, 48 hours and 1 week postoperatively | 
| change from baseline periapical index at 1 year | Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features. If scores varied among roots in the same tooth, the highest score was recorded for that tooth. Similarly, if scores varied between observers for the same tooth, the higher score was recorded. Treatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 . | Clinical and radiographic examinations were performed on the 1 day of treatment,1 day after treatment and 1 year after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic apical periodontitis, irrigation activation methods, periapical index, postoperative pain, treatment outcome