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Symptomatic Irreversible Pulpitis (SIP)NCT07882368

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

A study testing Conventional Needle Irrigation, Sonic Irrigation Activation and Cold Lateral Condensation in people with Symptomatic Irreversible Pulpitis (SIP) and Post Operative Pain After Root Canal Therapy, run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Conventional Needle Irrigation, Sonic Irrigation Activation and Cold Lateral Condensation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Nov 2024to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Biruni University

    Istanbul, In the USA Or Canada, Please Select..., 34010

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Conventional Needle Irrigation, Sonic Irrigation Activation, Cold Lateral Condensation, Thermoplasticized Gutta-Percha Obturation
Keywords
EDDY, Fast-Fill, Irrigation activation, Post-operative pain, Thermoplasticized gutta-percha obturation
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Needle IrrigationProcedure or surgery

    Final root canal irrigation was performed using conventional needle irrigation with 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA), without sonic activation.

  • Sonic Irrigation ActivationProcedure or surgery

    Also called EDDY

    Final irrigation was performed using 2.5% sodium hypochlorite (NaOCl) and 17% EDTA, activated with the EDDY sonic irrigation activation system.

  • Cold Lateral CondensationProcedure or surgery

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

  • Thermoplasticized Gutta-Percha ObturationProcedure or surgery

    Also called Fast-Fill

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

Study groups in NCT07882368
Study groupRoleWhat they receive
Group 1: Conventional Irrigation + CLCActive comparatorParticipants received conventional final irrigation followed by root canal obturation using the cold lateral condensation technique.
Receives: Procedure: Conventional Needle Irrigation; Procedure: Cold Lateral Condensation
Group 2 - EDDY + CLCExperimentalParticipants received final irrigation activation using the EDDY sonic activation system followed by root canal obturation using the cold lateral condensation technique.
Receives: Procedure: Sonic Irrigation Activation; Procedure: Cold Lateral Condensation
Group 3: Conventional Irrigation + Fast-FillExperimentalParticipants received conventional final irrigation followed by thermoplasticized root canal obturation using the Fast-Fill system.
Receives: Procedure: Conventional Needle Irrigation; Procedure: Thermoplasticized Gutta-Percha Obturation
Group 4: EDDY + Fast-FillExperimentalParticipants received final irrigation activation using the EDDY sonic activation system followed by thermoplasticized root canal obturation using the Fast-Fill system.
Receives: Procedure: Sonic Irrigation Activation; Procedure: Thermoplasticized Gutta-Percha Obturation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8, 24, and 48 hours and 7 days after treatment

Secondary outcomes (1)
  1. 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.

    Measured: Within 7 days after root canal treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start4 Nov 2024
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07882368
Sponsor's protocol ID
2015-KAEK-80-23-41
Other IDs
BİRUNİ-BAP-01-2023-01-04
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Needle Irrigation, Sonic Irrigation Activation and Cold Lateral Condensation in people with Symptomatic Irreversible Pulpitis (SIP) and Post Operative Pain After Root Canal Therapy, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity (time frame: 8, 24, and 48 hours and 7 days after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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