Mandibular Premolars and Canines With Asymptomatic Apical PeriodontitisNCT07410832
The Effect of Different Irrigation Methods Used During Endodontic Treatment on Postoperative Pain in Teeth With Periapical Lesions
A study testing Irrigation in people with Mandibular Premolars and Canines With Asymptomatic Apical Periodontitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of different irrigation activation methods used during endodontic treatment on postoperative pain in teeth with periapical lesions, allowing us to clinically determine which agitation technique causes less postoperative pain. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Premolars and Canines With Asymptomatic Apical Periodontitis
- What is being tested?
- Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Dec 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy patients aged 18-65 years, Patients with chronic apical periodontitis, Patients with a PAI score of 3-5, Mandibular canine and premolar teeth, Teeth without root resorption, periodontal disease, previous endodontic treatment, or calcification.
Who cannot join
- Patients with systemic diseases, Pregnant patients, Teeth with acute pain, Teeth with crown or root fractures, Patients who have used analgesic or anti-inflammatory drugs within the last 12 hours, Patients who have used antibiotics within the last 2 weeks, Immature teeth with open apices, Patients with missing consent or follow-up forms.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry Department of Endodontics
Antalya
About this study
The aim of this study is to evaluate the effect of different irrigation activation methods used during endodontic treatment on postoperative pain in teeth with periapical lesions, allowing us to clinically determine which agitation technique causes less postoperative pain.
Read the detailed description
Sample Size Determination and Patient Selection The sample size was calculated by reviewing relevant reference articles and pilot studies, using the G*Power 3 program. With a 95% confidence level, 80% power, and an effect size of 0.4, it was determined that at least 19 teeth per group were statistically required. To account for potential dropouts, it was decided to include 22 teeth per group, totaling 88 teeth in the study.
Patients were selected from individuals who met the inclusion and exclusion criteria listed below.
Inclusion criteria:
Healthy patients aged 18-65 years, Patients with chronic apical periodontitis, Teeth with PAI scores of 3-5, Mandibular canines and premolars, Teeth without root resorption, periodontal disease, previous endodontic treatment, or calcifications.
Exclusion criteria:
Patients with systemic diseases, Pregnant women, Teeth with acute pain, Teeth with crown or root fractures, Patients who used analgesics or anti-inflammatory drugs within the last 12 hours, Patients who used antibiotics in the past 2 weeks, Teeth with open apex or immature teeth, Patients with incomplete consent or follow-up forms. Treatment Protocol The study included patients treated at the Endodontics Clinic of the Faculty of Dentistry, Akdeniz University, following routine root canal treatment procedures. All treatments were performed by a single clinician. Data regarding patients' age, sex, systemic conditions, root canal anatomy, periapical status, irrigation activation method used during treatment, and postoperative pain intensity were obtained from patient records and follow-up forms.
Before the procedure, patients' medical and dental histories were recorded, and percussion and palpation sensitivities were assessed. Pulp vitality was evaluated using an electric pulp tester (Ai-Pex, Woodpecker, China) and a cold test (Cerkamed, Poland). Initial periapical radiographs were assessed, and teeth with PAI scores of 3, 4, or 5 were included, while teeth with scores of 1 or 2 were considered periapically healthy and excluded from the study.
Local anesthesia was administered using 1 ml of anesthetic solution containing 80 mg articaine hydrochloride and 0.024 mg epinephrine hydrochloride (Ultracain D-S forte, Sanofi, France) via a mental nerve block. Teeth were isolated using a rubber dam, and caries and existing restorations, if any, were removed using diamond burs to prepare a standard endodontic access cavity.
Working length was determined using #15 K-type hand files (Perfect, China) and an electronic apex locator (Woodpecker, Endo Radar Pro, China) and verified radiographically 0.5-1 mm short of the apex.
Root canal preparation was performed using an endodontic motor (Woodpecker, Endo Radar, China) and a nickel-titanium rotary file system (ProTaper Next; Dentsply-Sirona, Ballaigues, Switzerland) at 300 rpm and 2 N/cm torque. Apical preparation was completed with the X4 file. During shaping, files were removed when excessive apical resistance was encountered to prevent torsional overload, debris were cleaned from the files, and canals were irrigated.
Irrigation procedures were applied with different activation methods for four groups:
Group 1 (Control): During shaping, canals were irrigated with a total of 15 ml 2.5% NaOCl, 2 ml after each file change, using a 27G open-ended irrigation needle with 2-3 mm vertical movements, followed by recapitulation with a #15 K file. After preparation, canals were irrigated with 5 ml 17% EDTA (Endo-Solution, Cerkamed, Stalowa Wola, Poland) for 1 minute, followed by 5 ml distilled water to neutralize residual EDTA.
Group 2: Root canal preparation was performed as in Group 1. The EDDY tip was placed 2 mm short of the working length and activated in three cycles of 20 seconds each with 2-3 mm vertical movements. After each 20-second activation, 1 ml 2.5% NaOCl was applied to refresh the solution. Residual NaOCl was removed with 5 ml distilled water for 30 seconds. The canal was then irrigated with 2 ml 17% EDTA and activated in three 20-second cycles, adding 1 ml EDTA after each cycle. Residual EDTA was removed with 5 ml distilled water for 30 seconds.
Group 3: Root canal preparation and irrigation activation procedures were performed as in Group 2, but ultrasonic activation (DTE, Woodpecker, China) was used.
Group 4: Root canal preparation and irrigation activation procedures were performed as in Group 2, but XP-Finisher (FKG Dentaire, La Chaux-de-Fonds, Switzerland) was used.
Canals were dried with appropriate paper points (Meta Biomed, Korea) and obturated using gutta-percha (Diadent Group International, Canada) and an epoxy resin-based sealer (Dentac, Turkey) with lateral condensation technique. Temporary restorations were applied using chemically curing glass ionomer cement (Prime Dental Products, Prime Cem Restorative (Type 2), India) and occlusion was checked. Patients were prescribed 400 mg ibuprofen and advised to use it as needed. Permanent restorations were completed with light-cured composite (Coltene Whaledent Brilliant Ng, Switzerland) after one week, following collection of postoperative pain forms, and occlusion was checked.
Postoperative Pain Assessment Patients were provided with a postoperative pain assessment form including a Visual Analog Scale (VAS) and instructed to record their pain levels and analgesic use at 6, 24, 48, 72 hours, and on the 7th day. Patients returned for a follow-up visit after one week to submit the completed forms.
- Being tested
- Irrigation
- Keywords
- postoperative pain, periapical lesion, activation tecniques, irrigation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationProcedure or surgery
Irrigation procedures were performed with needles of different ırrigation devices
| Study group | Role | What they receive |
|---|---|---|
| Irrigation using conventional needle technique | Experimental | Irrigation of the root canals was performed using only the conventional needle technique Receives: Procedure: Irrigation |
| Irrigation using the Eddy system | Experimental | "Irrigation activation of the root canals was performed using the EDDY system Receives: Procedure: Irrigation |
| Irrigation using ultrasonic activation | Experimental | Root canal irrigation activation was performed using ultrasonic activation." Receives: Procedure: Irrigation |
| Irrigation using XP Finisher system | Experimental | Root canal irrigation activation was performed using the XP Finisher system. Receives: Procedure: Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain with VAS after root canal treatment
Measured: 6, 24, 48, 72 hours, and on the 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Premolars and Canines With Asymptomatic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Kırıcı, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410832
- Sponsor's protocol ID
- 759
- Other IDs
- No secondary ID
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Irrigation Methods Used During Endodontic Treatment on Postoperative Pain in Teeth With Periapical Lesions
- ClinicalTrials.gov ID
- NCT07410832
- Acronym / sponsor ID
- 759
- Keywords
- postoperative pain, periapical lesion, activation tecniques, irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 13 Feb 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.
The aim of this study is to evaluate the effect of different irrigation activation methods used during endodontic treatment on postoperative pain in teeth with periapical lesions, allowing us to clinically determine which agitation technique causes less postoperative pain.
Detailed description
Sample Size Determination and Patient Selection The sample size was calculated by reviewing relevant reference articles and pilot studies, using the G*Power 3 program. With a 95% confidence level, 80% power, and an effect size of 0.4, it was determined that at least 19 teeth per group were statistically required. To account for potential dropouts, it was decided to include 22 teeth per group, totaling 88 teeth in the study.
Patients were selected from individuals who met the inclusion and exclusion criteria listed below.
Inclusion criteria:
Healthy patients aged 18-65 years, Patients with chronic apical periodontitis, Teeth with PAI scores of 3-5, Mandibular canines and premolars, Teeth without root resorption, periodontal disease, previous endodontic treatment, or calcifications.
Exclusion criteria:
Patients with systemic diseases, Pregnant women, Teeth with acute pain, Teeth with crown or root fractures, Patients who used analgesics or anti-inflammatory drugs within the last 12 hours, Patients who used antibiotics in the past 2 weeks, Teeth with open apex or immature teeth, Patients with incomplete consent or follow-up forms. Treatment Protocol The study included patients treated at the Endodontics Clinic of the Faculty of Dentistry, Akdeniz University, following routine root canal treatment procedures. All treatments were performed by a single clinician. Data regarding patients' age, sex, systemic conditions, root canal anatomy, periapical status, irrigation activation method used during treatment, and postoperative pain intensity were obtained from patient records and follow-up forms.
Before the procedure, patients' medical and dental histories were recorded, and percussion and palpation sensitivities were assessed. Pulp vitality was evaluated using an electric pulp tester (Ai-Pex, Woodpecker, China) and a cold test (Cerkamed, Poland). Initial periapical radiographs were assessed, and teeth with PAI scores of 3, 4, or 5 were included, while teeth with scores of 1 or 2 were considered periapically healthy and excluded from the study.
Local anesthesia was administered using 1 ml of anesthetic solution containing 80 mg articaine hydrochloride and 0.024 mg epinephrine hydrochloride (Ultracain D-S forte, Sanofi, France) via a mental nerve block. Teeth were isolated using a rubber dam, and caries and existing restorations, if any, were removed using diamond burs to prepare a standard endodontic access cavity.
Working length was determined using #15 K-type hand files (Perfect, China) and an electronic apex locator (Woodpecker, Endo Radar Pro, China) and verified radiographically 0.5-1 mm short of the apex.
Root canal preparation was performed using an endodontic motor (Woodpecker, Endo Radar, China) and a nickel-titanium rotary file system (ProTaper Next; Dentsply-Sirona, Ballaigues, Switzerland) at 300 rpm and 2 N/cm torque. Apical preparation was completed with the X4 file. During shaping, files were removed when excessive apical resistance was encountered to prevent torsional overload, debris were cleaned from the files, and canals were irrigated.
Irrigation procedures were applied with different activation methods for four groups:
Group 1 (Control): During shaping, canals were irrigated with a total of 15 ml 2.5% NaOCl, 2 ml after each file change, using a 27G open-ended irrigation needle with 2-3 mm vertical movements, followed by recapitulation with a #15 K file. After preparation, canals were irrigated with 5 ml 17% EDTA (Endo-Solution, Cerkamed, Stalowa Wola, Poland) for 1 minute, followed by 5 ml distilled water to neutralize residual EDTA.
Group 2: Root canal preparation was performed as in Group 1. The EDDY tip was placed 2 mm short of the working length and activated in three cycles of 20 seconds each with 2-3 mm vertical movements. After each 20-second activation, 1 ml 2.5% NaOCl was applied to refresh the solution. Residual NaOCl was removed with 5 ml distilled water for 30 seconds. The canal was then irrigated with 2 ml 17% EDTA and activated in three 20-second cycles, adding 1 ml EDTA after each cycle. Residual EDTA was removed with 5 ml distilled water for 30 seconds.
Group 3: Root canal preparation and irrigation activation procedures were performed as in Group 2, but ultrasonic activation (DTE, Woodpecker, China) was used.
Group 4: Root canal preparation and irrigation activation procedures were performed as in Group 2, but XP-Finisher (FKG Dentaire, La Chaux-de-Fonds, Switzerland) was used.
Canals were dried with appropriate paper points (Meta Biomed, Korea) and obturated using gutta-percha (Diadent Group International, Canada) and an epoxy resin-based sealer (Dentac, Turkey) with lateral condensation technique. Temporary restorations were applied using chemically curing glass ionomer cement (Prime Dental Products, Prime Cem Restorative (Type 2), India) and occlusion was checked. Patients were prescribed 400 mg ibuprofen and advised to use it as needed. Permanent restorations were completed with light-cured composite (Coltene Whaledent Brilliant Ng, Switzerland) after one week, following collection of postoperative pain forms, and occlusion was checked.
Postoperative Pain Assessment Patients were provided with a postoperative pain assessment form including a Visual Analog Scale (VAS) and instructed to record their pain levels and analgesic use at 6, 24, 48, 72 hours, and on the 7th day. Patients returned for a follow-up visit after one week to submit the completed forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Irrigation using conventional needle technique | Experimental | Procedure: IrrigationIrrigation of the root canals was performed using only the conventional needle technique |
| Irrigation using the Eddy system | Experimental | Procedure: Irrigation"Irrigation activation of the root canals was performed using the EDDY system |
| Irrigation using ultrasonic activation | Experimental | Procedure: IrrigationRoot canal irrigation activation was performed using ultrasonic activation." |
| Irrigation using XP Finisher system | Experimental | Procedure: IrrigationRoot canal irrigation activation was performed using the XP Finisher system. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patients aged 18-65 years, Patients with chronic apical periodontitis, Patients with a PAI score of 3-5, Mandibular canine and premolar teeth, Teeth without root resorption, periodontal disease, previous endodontic treatment, or calcification.
Key exclusion criteria (1 listed)
- Patients with systemic diseases, Pregnant patients, Teeth with acute pain, Teeth with crown or root fractures, Patients who have used analgesic or anti-inflammatory drugs within the last 12 hours, Patients who have used antibiotics within the last 2 weeks, Immature teeth with open apices, Patients with missing consent or follow-up forms.
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 |
|---|---|---|
| IrrigationIrrigation procedures were performed with needles of different ırrigation devices | Procedure or surgery | Irrigation using XP Finisher system, Irrigation using conventional needle technique, Irrigation using the Eddy system, Irrigation using ultrasonic activation |
Primary outcome
Assessment of postoperative pain with VAS after root canal treatment
Time frame: 6, 24, 48, 72 hours, and on the 7th day
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 13 Feb 2026.
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 Irrigation in people with Mandibular Premolars and Canines With Asymptomatic Apical Periodontitis, run by Akdeniz 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 1 inclusion and 1 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 13 Feb 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?
Assessment of postoperative pain with VAS after root canal treatment (time frame: 6, 24, 48, 72 hours, and on the 7th day). 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 13 Feb 2026.