This randomized controlled clinical trial will evaluate whether sonic activation of the root canal irrigant using the EndoActivator system reduces postoperative pain after root canal treatment compared with conventional syringe irrigation.
Adults aged 18 to 60 years with pulp necrosis and asymptomatic apical periodontitis involving restorable permanent single-rooted premolars will be eligible to participate. A total of 176 participants will be randomly assigned in a 1:1 ratio to either conventional syringe irrigation or sonic irrigation activation using the EndoActivator system.
Root canal treatment procedures, including instrumentation, irrigant concentration and volume, irrigation delivery, obturation, and postoperative instructions, will be standardized between the two groups. The main difference between the groups will be the method used to activate the irrigant.
The primary outcome will be postoperative pain intensity measured using a 100-mm Visual Analog Scale (VAS) 24 hours after root canal treatment. Pain will also be assessed at 6, 48, and 72 hours and at 7 and 14 days. Additional outcomes will include the proportion of participants reporting pain, rescue analgesic use, time to first analgesic use, total analgesic consumption, and adverse events.
The study will be conducted in the Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Saidu Sharif, Swat, Khyber Pakhtunkhwa, Pakistan. Each participant will be followed for 14 days after treatment.
Adults aged 18-60 years.
Either sex.
Restorable permanent single-rooted premolar requiring primary root canal treatment.
Clinical diagnosis of pulp necrosis.
Symptomatic apical periodontitis or acute apical abscess.
Preoperative spontaneous pain.
Swelling or sinus tract.
Previously treated teeth.
Parallel
Sonic Irrigation Activation Using EndoActivator
Procedure/SurgerySonic activation of root canal irrigant will be performed using the EndoActivator system after delivery of the standardized final irrigation solution. The same irrigants, concentrations, volumes, sequence, and exposure times will be used in both treatment groups. A flexible polymer EndoActivator tip of appropriate size will be positioned approximately 1-2 mm short of the established working length without binding. The device will be operated using a prespecified activation protocol, with controlled movement within the irrigant-filled canal. Tip size, device setting, activation duration, number of activation cycles, and insertion depth will be recorded for each participant.
Conventional Syringe Irrigation
Procedure/SurgeryConventional irrigation will be performed using a sterile side-vented endodontic irrigation needle positioned approximately 1-2 mm short of the established working length without binding. Irrigation will be performed using gentle, standardized short vertical movements. The same irrigants, concentrations, volumes, sequence, and exposure times will be used as in the sonic activation group. No mechanical activation device will be used.
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 mm representing no pain and 100 mm representing the worst imaginable pain. Higher VAS scores indicate greater postoperative pain.
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS) at Follow-Up
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 mm representing no pain and 100 mm representing the worst imaginable pain. Higher VAS scores indicate greater postoperative pain.
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