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).
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
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP), Post Operative Pain After Root Canal Therapy
- 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
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 group | Role | What they receive |
|---|---|---|
| Group 1: Conventional Irrigation + CLC | Active comparator | Participants 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 + CLC | Experimental | Participants 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-Fill | Experimental | Participants 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-Fill | Experimental | Participants 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.
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)
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.
- First posted20 Oct 2026
- Study start4 Nov 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuna Kaplan, DDS, PhD, Principal investigator, Biruni University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07882368
- Acronym / sponsor ID
- 2015-KAEK-80-23-41
- Keywords
- EDDY, Fast-Fill, Irrigation activation, Post-operative pain, Thermoplasticized gutta-percha obturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Conventional Irrigation + CLC | Active comparator | Procedure: Conventional Needle Irrigation, Procedure: Cold Lateral CondensationParticipants received conventional final irrigation followed by root canal obturation using the cold lateral condensation technique. |
| Group 2 - EDDY + CLC | Experimental | Procedure: Sonic Irrigation Activation, Procedure: Cold Lateral CondensationParticipants received final irrigation activation using the EDDY sonic activation system followed by root canal obturation using the cold lateral condensation technique. |
| Group 3: Conventional Irrigation + Fast-Fill | Experimental | Procedure: Conventional Needle Irrigation, Procedure: Thermoplasticized Gutta-Percha ObturationParticipants received conventional final irrigation followed by thermoplasticized root canal obturation using the Fast-Fill system. |
| Group 4: EDDY + Fast-Fill | Experimental | Procedure: Sonic Irrigation Activation, Procedure: Thermoplasticized Gutta-Percha ObturationParticipants received final irrigation activation using the EDDY sonic activation system followed by thermoplasticized root canal obturation using the Fast-Fill system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Needle IrrigationFinal root canal irrigation was performed using conventional needle irrigation with 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA), without sonic activation. | Procedure or surgery | Group 1: Conventional Irrigation + CLC, Group 3: Conventional Irrigation + Fast-Fill |
| Sonic Irrigation ActivationAlso: EDDYFinal irrigation was performed using 2.5% sodium hypochlorite (NaOCl) and 17% EDTA, activated with the EDDY sonic irrigation activation system. | Procedure or surgery | Group 2 - EDDY + CLC, Group 4: EDDY + Fast-Fill |
| Cold Lateral CondensationRoot canals were obturated using the cold lateral condensation technique with gutta-percha cones and AH Plus root canal sealer. | Procedure or surgery | Group 1: Conventional Irrigation + CLC, Group 2 - EDDY + CLC |
| Thermoplasticized Gutta-Percha ObturationAlso: Fast-FillRoot canals were obturated using thermoplasticized gutta-percha with the Fast-Pack and Fast-Fill systems and AH Plus root canal sealer. | Procedure or surgery | Group 3: Conventional Irrigation + Fast-Fill, Group 4: EDDY + Fast-Fill |
Primary outcome
Postoperative Pain Intensity
Time frame: 8, 24, and 48 hours and 7 days after treatment
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.
1 secondary outcome
Postoperative Analgesic Consumption
Time frame: Within 7 days after root canal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuna Kaplan, DDS, PhD principal investigator
Biruni University
1 site in 1 country: see every site and its status.
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.