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Effects of Irrigation Activation and Obturation Techniques on Pain After Root Canal Treatment

Comparison of Sonic Irrigation Activation and Thermoplasticized Obturation Techniques on Postoperative Pain After Single-Visit Root Canal Treatment: A Randomized Controlled Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07882368
Enrollment
72
Registered
2026-10-20
Start date
2024-11-04
Completion date
2025-09-01
Last updated
2026-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Irreversible Pulpitis (SIP), Post Operative Pain After Root Canal Therapy

Keywords

EDDY, Fast-Fill, Irrigation activation, Post-operative pain, Thermoplasticized gutta-percha obturation

Brief summary

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.

Detailed description

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.

Interventions

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.

PROCEDURECold Lateral Condensation

Root canals were obturated using the cold lateral condensation technique with gutta-percha cones and AH Plus root canal sealer.

PROCEDUREThermoplasticized Gutta-Percha Obturation

Root canals were obturated using thermoplasticized gutta-percha with the Fast-Pack and Fast-Fill systems and AH Plus root canal sealer.

Sponsors

Biruni University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and evaluating clinicians were blinded to the treatment procedures. In addition, the statistician was blinded to group allocation during data analysis. The treatment groups were identified using assigned numerical codes.

Intervention model description

This study used a four-arm parallel-group design. Participants were randomly allocated to four groups according to the combination of final irrigation technique (conventional needle irrigation or EDDY sonic activation) and root canal obturation technique (cold lateral condensation or thermoplasticized obturation). Each group included 18 participants.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adults aged 18-65 years without any medical conditions. * No history of allergic reactions to any components employed in this research. * Patients presenting with symptomatic irreversible pulpitis in permanent single-rooted teeth with a single canal, exhibiting closed apices. * Patients with no signs of periodontal disease.

Exclusion criteria

* Pregnant women. * Patients diagnosed with systemic diseases. * Teeth with open apices, prosthetic restorations, grade II or higher mobility, periodontal pocket depths \>4 mm, unrestorable status, root canal calcification, resorptive defects, traumatic occlusion, requiring a post-core restoration, and a history of previous endodontic treatment. * Presence of an adjacent tooth requiring endodontic therapy. * Patients with a history of analgesic intake in the 12 hours prior to the procedure.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Intensity8, 24, and 48 hours and 7 days after treatmentPostoperative 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.

Secondary

MeasureTime frameDescription
Postoperative Analgesic ConsumptionWithin 7 days after root canal treatmentPostoperative 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORTuna Kaplan, DDS, PhD

Biruni University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 21, 2026