An interventional study of Conventional Needle Irrigation and Sonic Irrigation Activation in Symptomatic Irreversible Pulpitis (SIP) and Post Operative Pain After Root Canal Therapy, sponsored by Biruni University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial aimed to compare postoperative pain and analgesic use following single-visit root canal treatment performed using different final irrigation activation and root canal obturation techniques in patients with symptomatic irreversible pulpitis.
A total of 72 adult patients aged 18 to 65 years with symptomatic irreversible pulpitis in permanent single rooted, single canal teeth were randomly assigned to four treatment groups (18 patients in each group). The groups received conventional needle irrigation with cold lateral condensation, EDDY sonic irrigation activation with cold lateral condensation, conventional needle irrigation with Fast-Fill thermoplasticized obturation, or EDDY sonic irrigation activation with Fast-Fill thermoplasticized obturation.
All treatments were completed in a single visit using standardized root canal preparation procedures. Pain intensity was recorded using a 0-10 Numerical Rating Scale before treatment and at 8, 24, and 48 hours and 7 days after treatment. The use of pain-relieving medication was also recorded.
The study was designed to determine whether irrigation activation and obturation techniques influence postoperative pain and analgesic consumption following root canal treatment.
This prospective, parallel-group randomized controlled clinical trial was conducted at the Department of Endodontics, Faculty of Dentistry, Biruni University, Istanbul, Türkiye. The study included 72 patients aged 18-65 years diagnosed with symptomatic irreversible pulpitis in permanent single rooted teeth with a single root canal and closed apices. Ethical approval was obtained from the Biruni University Ethics Committee (2015-KAEK-80-23-41), and written informed consent was obtained from all participants.
An a priori sample size calculation was performed using G*Power 3.1, assuming an effect size of 0.79, a significance level of 0.05, and 80% statistical power. The minimum required sample size was 14 participants per group. To account for potential dropout, 18 participants were enrolled in each of the four groups.
Participants were randomly allocated to four parallel groups using a computer-generated randomization sequence prepared by an individual not involved in the study. Group assignments were concealed in sealed opaque envelopes until treatment. Participants were not informed of the specific treatment technique assigned to them.
All root canal treatments were performed in a single appointment by one experienced endodontist. Following local anesthesia and rubber dam isolation, working length was determined using an electronic apex locator and confirmed radiographically. Root canals were prepared using the XP-endo Rise Glider and XP-endo Rise Shaper systems. The instrumentation protocol was standardized across all groups.
Group 1 received conventional needle final irrigation with 2.5% sodium hypochlorite and 17% EDTA, followed by cold lateral condensation using gutta-percha and AH Plus sealer.
Group 2 received sonic activation of 2.5% sodium hypochlorite and 17% EDTA using the EDDY system, followed by cold lateral condensation using gutta-percha and AH Plus sealer.
Group 3 received conventional needle final irrigation followed by thermoplasticized gutta-percha obturation using the Fast-Pack and Fast-Fill systems with AH Plus sealer.
Group 4 received EDDY sonic irrigation activation followed by thermoplasticized gutta-percha obturation using the Fast-Pack and Fast-Fill systems with AH Plus sealer.
Following obturation, the quality of the root canal filling was assessed radiographically, and definitive coronal restorations were completed using composite resin.
Postoperative pain intensity was assessed using an 11-point Numerical Rating Scale ranging from 0 (no pain) to 10 (worst pain) before treatment and at 8 hours, 24 hours, 48 hours, and 7 days after treatment. Participants recorded pain scores and analgesic consumption on standardized forms. Ibuprofen 600 mg every 8 hours was recommended when needed for pain relief; paracetamol 500 mg was recommended when ibuprofen was unsuitable. Completed assessment forms were collected at the one-week follow-up visit.
The primary outcome was postoperative pain intensity. Analgesic consumption was additionally evaluated. Statistical analyses were performed using nonparametric methods, with statistical significance set at p \< 0.05.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 72 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Participants received conventional final irrigation followed by root canal obturation using the cold lateral condensation technique.
Procedure: Conventional Needle Irrigation · Procedure: Cold Lateral Condensation
Participants received final irrigation activation using the EDDY sonic activation system followed by root canal obturation using the cold lateral condensation technique.
Procedure: Sonic Irrigation Activation · Procedure: Cold Lateral Condensation
Participants received conventional final irrigation followed by thermoplasticized root canal obturation using the Fast-Fill system.
Procedure: Conventional Needle Irrigation · Procedure: Thermoplasticized Gutta-Percha Obturation
Participants received final irrigation activation using the EDDY sonic activation system followed by thermoplasticized root canal obturation using the Fast-Fill system.
Procedure: Sonic Irrigation Activation · Procedure: Thermoplasticized Gutta-Percha Obturation
Final root canal irrigation was performed using conventional needle irrigation with 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA), without sonic activation.
Final irrigation was performed using 2.5% sodium hypochlorite (NaOCl) and 17% EDTA, activated with the EDDY sonic irrigation activation system.
Also known as: EDDY
Root canals were obturated using the cold lateral condensation technique with gutta-percha cones and AH Plus root canal sealer.
Root canals were obturated using thermoplasticized gutta-percha with the Fast-Pack and Fast-Fill systems and AH Plus root canal sealer.
Also known as: Fast-Fill
Postoperative Pain Intensity
Postoperative pain intensity was assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants recorded their pain intensity at predetermined intervals following single-visit root canal treatment. Higher scores indicated greater pain intensity.
Time frame: 8, 24, and 48 hours and 7 days after treatment
Postoperative Analgesic Consumption
Postoperative analgesic consumption was assessed based on participants' self-reported use of pain-relieving medication following root canal treatment. Participants recorded their analgesic intake during the postoperative follow-up period using standardized assessment forms.
Time frame: Within 7 days after root canal treatment
Plan to share: No
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Ran from Nov 2024 to primary completion in Sep 2025, 9 months.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 9 months is below that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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