This clinical study is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. Postoperative pain following root canal treatment may affect patient comfort and satisfaction. The choice of irrigation agitation technique and root canal sealer may influence these outcomes. Irrigation agitation techniques are used to improve cleaning of the root canal system. XP-Endo Finisher, EDDY, and passive ultrasonic activation use different mechanisms to enhance this process. Root canal sealers, including the epoxy resin-based AH Plus and the calcium silicate-based NeoSealer Flo, also differ in their composition and biological properties. Clinical evidence regarding the combined effects of these techniques and sealers on patient-reported outcomes remains limited. In this randomized clinical trial, 324 patients aged 18-65 years requiring root canal treatment for a single-rooted, single-canal permanent tooth with symptomatic irreversible pulpitis will be allocated to six groups. Each group will receive one of three irrigation agitation techniques-XP-Endo Finisher, EDDY, or passive ultrasonic activation-in combination with either AH Plus or NeoSealer Flo. Root canal treatment will be completed in a single visit. Postoperative pain intensity will be assessed using a visual analog scale at 6, 12, 24, 48, and 72 hours and 7 days after treatment. Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 questionnaire before treatment and 7 days afterward. Analgesic use during the follow-up period will also be recorded. The primary objective is to compare postoperative pain among the six treatment groups. Secondary objectives include evaluating changes in oral health-related quality of life and analgesic consumption. The study will also investigate whether irrigation agitation techniques and root canal sealers have interacting effects on postoperative pain. The findings may help clinicians select irrigation agitation techniques and root canal sealers that support patient comfort and improve the patient experience following root canal treatment.
• Patients with single-rooted teeth requiring endodontic retreatment.
Individuals in good general health, classified as ASA Physical Status I.
Teeth presenting normal anatomical structure and root morphology.
Patients who have used antibiotics or analgesic medications within the last month.
Pregnant individuals and patients with systemic diseases (such as chronic illnesses, diabetes mellitus, hypertension).
Teeth with root fractures or perforations.
Patients presenting with high baseline pain levels, particularly those with a history of treatment-resistant pain.
Parallel
XP-Endo Finisher
DrugXP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.
EDDY
DrugEDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.
Passive Ultrasonic Activation
DrugPassive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.
AH Plus
DrugAH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.
NeoSealer Flo
DrugNeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.
6
Treatment groupsSee each treatment group below.
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a patient-reported Visual Analog Scale (VAS). The VAS consists of a 10-cm line anchored at 0 cm ("no pain") and 10 cm ("worst imaginable pain"). Participants will mark their pain intensity on the line. Scores will range from 0 to 10, with higher scores indicating greater pain intensity. The measurement unit will be the VAS score.
Change in Oral Health-Related Quality of Life
Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and 7 days after treatment. The questionnaire consists of 14 items, each scored from 0 ("never") to 4 ("very often"), yielding a total score ranging from 0 to 56. Higher scores indicate a greater adverse impact on oral health-related quality of life. Change will be calculated as the day-7 score minus the baseline score; negative values indicate improvement.
Analgesic Consumption
Analgesic use for postoperative pain control will be recorded during the seven-day follow-up period and compared among the six treatment groups.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
