Post Operative PainNCT07170098
Post-operative Pain After Different Irrigation and Disinfection Methods in Single-rooted Teeth
A study testing EDDY sonic irrigation system, EndoActivator (EA) sonic irrigation system and 980-nm diode laser in people with Post Operative Pain and Apical Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial aimed to evaluate post-operative pain (PP) in single-rooted teeth with asymptomatic apical periodontitis following final irrigation with sonic activation systems (EDDY and EndoActivator), with and without adjunctive 980-nm diode laser disinfection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Apical Periodontitis, Asymptomatic Infections
- What is being tested?
- EDDY sonic irrigation system, EndoActivator (EA) sonic irrigation system and 980-nm diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2025to 31 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically healthy adult patients aged 18-65 years
- Patients diagnosed with asymptomatic apical periodontitis in permanent single-rooted teeth with closed apices and radiographic PAI score of 3 or 4
- Healthy periodontal conditions
Who cannot join
- Pregnant women
- Patients with systemic disorders
- Teeth with open apex, prosthetic restorations, mobility > grade I, periodontal pocket depth > 4 mm, non-restorable condition, calcified root canals, resorption, traumatic occlusion, or history of previous endodontic treatment
- Patients who had taken analgesics within 12 hours prior to intervention
- Patients who had received antibiotic therapy within the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Pain Following Different Irrigation Activation and Disinfection Approaches in Single-rooted Teeth With Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
This randomized clinical trial aimed to evaluate post-operative pain (PP) in single-rooted teeth with asymptomatic apical periodontitis following final irrigation with sonic activation systems (EDDY and EndoActivator), with and without adjunctive 980-nm diode laser disinfection. Eighty patients were randomized into four groups: Group 1 (EDDY), Group 2 (EndoActivator), Group 3 (EDDY + laser), and Group 4 (EndoActivator + laser). PP intensity and analgesic intake were recorded at 8, 24, 48 hours, and on day 7. The study found no significant differences in PP or analgesic use among the groups, indicating that laser-assisted or different sonic activation methods did not reduce post-operative pain.
Read the detailed description
Post-operative pain (PP) is a common concern following root canal treatment, influenced by mechanical, chemical, and microbial factors. Effective irrigation and disinfection are crucial to remove debris and microorganisms from complex canal systems. This study investigated the effects of two sonic irrigation activation systems, EDDY and EndoActivator (EA), with and without 980-nm diode laser disinfection, on PP in patients with single-rooted teeth diagnosed with asymptomatic apical periodontitis.
Eighty medically healthy adult patients (18-65 years) were randomly assigned to four groups. Group 1 underwent final irrigation with EDDY; Group 2 with EA; Group 3 with EDDY followed by laser irradiation; Group 4 with EA followed by laser irradiation. All procedures were completed in a single visit. PP was measured using a 0-10 numerical rating scale at 8, 24, 48 hours, and day 7. Analgesic consumption was also recorded.
Statistical analysis showed no significant differences among groups for age, sex, PP scores, or analgesic intake. None of the patients experienced severe pain or swelling requiring emergency intervention. The findings suggest that both EDDY and EA sonic irrigation systems, with or without adjunctive 980-nm diode laser disinfection, do not significantly affect post-operative pain or analgesic use following single-visit root canal treatment of asymptomatic apical periodontitis.
These results provide insight into the effectiveness of sonic irrigation activation and laser disinfection in routine endodontic practice, indicating that alternative techniques may be explored to optimize patient comfort and treatment outcomes.
- Being tested
- EDDY sonic irrigation system, EndoActivator (EA) sonic irrigation system, 980-nm diode laser
- Keywords
- Asymptomatic apical periodontitis, Diode laser, EDDY, EndoActivator, Post-operative pain
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDDY sonic irrigation systemDevice
Sonic activation of irrigating solutions during endodontic treatment.
EndoActivator (EA) sonic irrigation systemDevice
Sonic activation of irrigating solutions during endodontic treatment.
980-nm diode laserDevice
Diode laser irradiation during endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| EDDY sonic irrigation | Experimental | Final irrigation activation was performed using the EDDY sonic system with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied. Receives: Device: EDDY sonic irrigation system |
| EndoActivator (EA) sonic irrigation | Experimental | Final irrigation activation was performed using the EndoActivator (EA) medium tip with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied. Receives: Device: EndoActivator (EA) sonic irrigation system |
| EDDY sonic irrigation + 980-nm diode laser | Experimental | Final irrigation activation was performed using the EDDY sonic system as in Arm 1, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode). Receives: Device: EDDY sonic irrigation system; Device: 980-nm diode laser |
| EndoActivator (EA) sonic irrigation + 980-nm diode laser | Experimental | Final irrigation activation was performed using the EndoActivator (EA) system as in Arm 2, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode). Receives: Device: EndoActivator (EA) sonic irrigation system; Device: 980-nm diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain intensity
Pain intensity was self-reported by patients using a numerical rating scale (0-10), where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 8, 24, and 48 hours, and 7 days after the endodontic procedure
Secondary outcomes (1)
Analgesic consumption
Patients recorded the type, dosage, and timing of analgesics taken during the postoperative period.
Measured: 8, 24, and 48 hours, and 7 days after the endodontic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start10 Aug 2025
- Primary completion11 Aug 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Parallel-group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Sönmez Kaplan, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170098
- Sponsor's protocol ID
- BİRUNİ-BAP-01-2023-01-05
- Other IDs
- BİRUNİ-BAP-01-2023-01-05
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Following Different Irrigation Activation and Disinfection Approaches in Single-rooted Teeth With Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07170098
- Acronym / sponsor ID
- BİRUNİ-BAP-01-2023-01-05
- Keywords
- Asymptomatic apical periodontitis, Diode laser, EDDY, EndoActivator, Post-operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Sep 2025 (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 clinical trial aimed to evaluate post-operative pain (PP) in single-rooted teeth with asymptomatic apical periodontitis following final irrigation with sonic activation systems (EDDY and EndoActivator), with and without adjunctive 980-nm diode laser disinfection. Eighty patients were randomized into four groups: Group 1 (EDDY), Group 2 (EndoActivator), Group 3 (EDDY + laser), and Group 4 (EndoActivator + laser). PP intensity and analgesic intake were recorded at 8, 24, 48 hours, and on day 7. The study found no significant differences in PP or analgesic use among the groups, indicating that laser-assisted or different sonic activation methods did not reduce post-operative pain.
Detailed description
Post-operative pain (PP) is a common concern following root canal treatment, influenced by mechanical, chemical, and microbial factors. Effective irrigation and disinfection are crucial to remove debris and microorganisms from complex canal systems. This study investigated the effects of two sonic irrigation activation systems, EDDY and EndoActivator (EA), with and without 980-nm diode laser disinfection, on PP in patients with single-rooted teeth diagnosed with asymptomatic apical periodontitis.
Eighty medically healthy adult patients (18-65 years) were randomly assigned to four groups. Group 1 underwent final irrigation with EDDY; Group 2 with EA; Group 3 with EDDY followed by laser irradiation; Group 4 with EA followed by laser irradiation. All procedures were completed in a single visit. PP was measured using a 0-10 numerical rating scale at 8, 24, 48 hours, and day 7. Analgesic consumption was also recorded.
Statistical analysis showed no significant differences among groups for age, sex, PP scores, or analgesic intake. None of the patients experienced severe pain or swelling requiring emergency intervention. The findings suggest that both EDDY and EA sonic irrigation systems, with or without adjunctive 980-nm diode laser disinfection, do not significantly affect post-operative pain or analgesic use following single-visit root canal treatment of asymptomatic apical periodontitis.
These results provide insight into the effectiveness of sonic irrigation activation and laser disinfection in routine endodontic practice, indicating that alternative techniques may be explored to optimize patient comfort and treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EDDY sonic irrigation | Experimental | Device: EDDY sonic irrigation systemFinal irrigation activation was performed using the EDDY sonic system with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied. |
| EndoActivator (EA) sonic irrigation | Experimental | Device: EndoActivator (EA) sonic irrigation systemFinal irrigation activation was performed using the EndoActivator (EA) medium tip with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied. |
| EDDY sonic irrigation + 980-nm diode laser | Experimental | Device: EDDY sonic irrigation system, Device: 980-nm diode laserFinal irrigation activation was performed using the EDDY sonic system as in Arm 1, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode). |
| EndoActivator (EA) sonic irrigation + 980-nm diode laser | Experimental | Device: EndoActivator (EA) sonic irrigation system, Device: 980-nm diode laserFinal irrigation activation was performed using the EndoActivator (EA) system as in Arm 2, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically healthy adult patients aged 18-65 years
- Patients diagnosed with asymptomatic apical periodontitis in permanent single-rooted teeth with closed apices and radiographic PAI score of 3 or 4
- Healthy periodontal conditions
Key exclusion criteria (5 listed)
- Pregnant women
- Patients with systemic disorders
- Teeth with open apex, prosthetic restorations, mobility > grade I, periodontal pocket depth > 4 mm, non-restorable condition, calcified root canals, resorption, traumatic occlusion, or history of previous endodontic treatment
- Patients who had taken analgesics within 12 hours prior to intervention
- Patients who had received antibiotic therapy within the past month
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 |
|---|---|---|
| EDDY sonic irrigation systemSonic activation of irrigating solutions during endodontic treatment. | Device | EDDY sonic irrigation, EDDY sonic irrigation + 980-nm diode laser |
| EndoActivator (EA) sonic irrigation systemSonic activation of irrigating solutions during endodontic treatment. | Device | EndoActivator (EA) sonic irrigation, EndoActivator (EA) sonic irrigation + 980-nm diode laser |
| 980-nm diode laserDiode laser irradiation during endodontic treatment. | Device | EDDY sonic irrigation + 980-nm diode laser, EndoActivator (EA) sonic irrigation + 980-nm diode laser |
Primary outcome
Post-operative pain intensity
Time frame: 8, 24, and 48 hours, and 7 days after the endodontic procedure
Pain intensity was self-reported by patients using a numerical rating scale (0-10), where 0 indicates no pain and 10 indicates the worst possible pain.
1 secondary outcome
Analgesic consumption
Time frame: 8, 24, and 48 hours, and 7 days after the endodontic procedure
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 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDDY sonic irrigation system, EndoActivator (EA) sonic irrigation system and 980-nm diode laser in people with Post Operative Pain and Apical Periodontitis, 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 3 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 12 Jan 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?
Post-operative pain intensity (time frame: 8, 24, and 48 hours, and 7 days after the endodontic procedure). 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 12 Jan 2026.