Effect of Passive Ultrasonic Irrigation Versus Needle Irrigation on Postoperative Pain and Periapical Healing

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.

Detailed Description
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Full medical and dental history using a dental chart for all patients treated in this study. Clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter. The treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. Endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and Endo-Z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. During mechanical preparation, irrigation will be done using passive ultrasonic irrigation (Experimental group) where ultrasonic activation will be done for irrigant-filled canals using the U- file tip (Varios NSK) in an ultrasonic device (P5 Newtron; Satelec Acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (Control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.

Official Title
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Comparison of Postoperative Pain and Healing After Passive Ultrasonic Irrigation and Needle Irrigation in Patients With Apical Periodontitis: A Randomized Clinical Trial

Conditions
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Apical Periodontitis

Intervention / Treatment
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* Device: Passive ultrasonic irrigation
* Device: Endodontic needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-55 years old. Males and females. Positive patient's acceptance to participate in the study. Mature, permanent, mandibular, posterior teeth with apical periodontitis. Exclusion Criteria: Medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy. Patients who had received analgesic treatment recently (past 8 hours) as it can affect the results Pregnant females. Teeth with previous root canal treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: Needle irrigation<br>Endodontic irrigation will be done using an endodontic needle. | Device: Endodontic needle<br>* Endodontic irrigation<br>|
| Experimental: Passive ultrasonic irrigation<br>Endodontic passive ultrasonic irrigation will be done using an endodontic needle followed by passive ultrasonic agitation. | Device: Passive ultrasonic irrigation<br>* Endodontic irrigation followed by passive ultrasonic agitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | postoperative pain will be assessed using numerical rate scale (NRS). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periapical healing | Periapical healing will be assessed using periapical index (PAI). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonic irrigation, pain, healing, apical periodontitis