Lower Molars With Irreversible PulpitisNCT07080918
EFFECTS OF IRRIGATION NEEDLES WITH DIFFERENT DESIGNS USED DURING ENDODONTIC TREATMENT ON POSTOPERATIVE PAIN
A study testing Irrigation in people with Lower Molars With Irreversible Pulpitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to comparatively evaluate the effects of different irrigation needle designs used during endodontic treatment on postoperative pain and to provide information on which needle designs may be more advantageous in clinical applications based on the findings obtained. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Molars With Irreversible Pulpitis
- 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
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Aug 2024
- 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
- Healthy patients ranging between 18 and 65 years in age,
- Patients with preoperative pain score ranging from moderate to severe (4-10) on a visual analog scale (VAS, 0-10)
- Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Patients with systemic diseases,
- Pregnancy or lactation
- Teeth with periapical lesions,
- Teeth that previous root canal treatment,
- Teeth with calcified canals,
- Teeth with periodontal diseases,
Show all 14Show fewer
- Teeth with sensitivite to percussion and palpation,
- Teeth with bruxism/traumatic occlusion,
- Teeth with crown or root fractures,
- Teeth with internal or external resorption,
- Teeth with immature/open apex,
- Patients who had taken antibiotics in the last two weeks,
- Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours,
- Patients missing consent and follow-up forms.
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to comparatively evaluate the effects of different irrigation needle designs used during endodontic treatment on postoperative pain and to provide information on which needle designs may be more advantageous in clinical applications based on the findings obtained.
Read the detailed description
In this study, the mandibular molars of patients aged 18-65 who were diagnosed with symptomatic irreversible pulpitis and underwent root canal treatment at the Endodontics Clinic of Akdeniz University Faculty of Dentistry between January 2023 and January 2024 were included. Postoperative pain assessment forms obtained during the routine follow-up of the patients were included in the study.The study included patients who underwent routine root canal treatment procedures at the Endodontics clinic of Akdeniz University Faculty of Dentistry, where the treatments were performed by a single dentist. The age, gender, systemic diseases, root canal structure, periapical condition, irrigation needle design used during endodontic treatment, and pre- and post-treatment pain severity of the patients included in the study were obtained from patient records and follow-up forms.
Before the procedure, the patients' medical and dental histories were taken, and preoperative pain levels were recorded. Each patient received an inferior alveolar nerve block using a 2 ml local anesthetic solution (Ultracain D-S forte, Sanofi, France) containing 80 mg articaine hydrochloride and 0.024 mg epinephrine hydrochloride. After the teeth related to the rubber dam were isolated, caries and any existing restorations were removed using diamond burs, and a standard endodontic access cavity was prepared.
For canal length determination, #10 K-type (Perfect, China) hand files were used, and the working length was determined with an electronic apex locator (Woodpecker, Endo Radar Pro, China) and confirmed radiologically.
Root canal preparation was performed using an endodontic motor (Woodpecker, Endo Radar Pro, China) and a nickel-titanium rotary instrument system (Scope Endodontic System, Turkey) at a speed of 300 rpm and a torque of 2 N/cm. Apical preparation was completed to a size three larger. During shaping, at the point where apical resistance was encountered, excessive torsional loading was prevented by removing the files from the canal, cleaning the debris from the files, and irrigating the root canals.
During the shaping process, the root canals were rinsed with 2 ml of 2.5% NaOCl after each file change and recapitulated with a #10K file. After the root canal preparation procedure was completed, each canal was rinsed with 5 ml of 2.5% NaOCl, and the NaOCl solution was activated using an endoactivator in three 20-second cycles. 5 ml of distilled water was applied to remove NaOCl residues from the canal. Then, 2 ml of 17% EDTA (Endo-Solution, Cerkamed, Stalowa Wola, Poland) was applied for 1 minute. To neutralize the EDTA residues, each canal was finally irrigated with 5 ml of distilled water.
Irrigation procedures were performed with needles of different designs, each 30 G, for three different groups:
For group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland) was used, For group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey) was used, For group 3, a closed-ended double orifice irrigation needle (Double Sideport, Raito, China) was used.
The irrigation needles were used 2 mm shorter than the working length. The root canals were shaped using appropriate paper points (Meta Biomed, Korea). The root canals were filled using the lateral condensation technique with gutta-percha (Diadent Group International, Canada) and epoxy resin-based root canal paste (Dentac, Turkey). The permanent restoration was completed with light-curing composite (Coltene Whaledent Brilliant Ng, Switzerland), and occlusal adjustment was checked. Patients were prescribed 400 mg of ibuprofen and advised to use it when absolutely necessary.Evaluation of Postoperative Pain Patients were given a postoperative pain assessment form that included a visual analog scale (VAS) to evaluate their postoperative pain levels. Patients were informed about the topic and asked to record their pain levels and analgesic usage on the provided form at 6, 24, 48, 72 hours, and on the 7th day. Patients were called for a follow-up session one week later, and the given forms were collected.
- Conditions
- Lower Molars With Irreversible Pulpitis
- Being tested
- Irrigation
- Keywords
- root canal treatment, conventional needle irrigation, irrigation needle design, postoperative pain
- 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 designs, each 30 G, for three different groups
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | For group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland)Raito, China) Receives: Procedure: Irrigation |
| Group 2 | Experimental | For group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey) Receives: Procedure: Irrigation |
| Group 3 | Experimental | For group 3,a closed-ended double orifice irrigation needle (Double Sideport, Raito, China) 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 posted23 Jul 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Molars With Irreversible PulpitisStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Kırıcı, Akdeniz University
- Investigators
- Damla Kırıcı, Associate Prof, Study chair, Akdeniz UniversityDamla Kırıcı, ASSOCİATE PROF, Study chair, AkdenizUniversityDAMLA KIRICI, ASSOCİATE PROF, Study chair, AKDENİZ UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080918
- Sponsor's protocol ID
- 143
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yersel A, Kirici D. The effect of the design of the irrigation needle used during endodontic treatment on postoperative pain: a randomize clinical trial. Sci Rep. 2026 Jan 7;16(1):4452. doi: 10.1038/s41598-025-34420-6.
PubMed 41501119
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF IRRIGATION NEEDLES WITH DIFFERENT DESIGNS USED DURING ENDODONTIC TREATMENT ON POSTOPERATIVE PAIN
- ClinicalTrials.gov ID
- NCT07080918
- Acronym / sponsor ID
- 143
- Conditions
- Lower Molars With Irreversible Pulpitis
- Keywords
- root canal treatment, conventional needle irrigation, irrigation needle design, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 23 Jul 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 study is aimed to comparatively evaluate the effects of different irrigation needle designs used during endodontic treatment on postoperative pain and to provide information on which needle designs may be more advantageous in clinical applications based on the findings obtained.
Detailed description
In this study, the mandibular molars of patients aged 18-65 who were diagnosed with symptomatic irreversible pulpitis and underwent root canal treatment at the Endodontics Clinic of Akdeniz University Faculty of Dentistry between January 2023 and January 2024 were included. Postoperative pain assessment forms obtained during the routine follow-up of the patients were included in the study.The study included patients who underwent routine root canal treatment procedures at the Endodontics clinic of Akdeniz University Faculty of Dentistry, where the treatments were performed by a single dentist. The age, gender, systemic diseases, root canal structure, periapical condition, irrigation needle design used during endodontic treatment, and pre- and post-treatment pain severity of the patients included in the study were obtained from patient records and follow-up forms.
Before the procedure, the patients' medical and dental histories were taken, and preoperative pain levels were recorded. Each patient received an inferior alveolar nerve block using a 2 ml local anesthetic solution (Ultracain D-S forte, Sanofi, France) containing 80 mg articaine hydrochloride and 0.024 mg epinephrine hydrochloride. After the teeth related to the rubber dam were isolated, caries and any existing restorations were removed using diamond burs, and a standard endodontic access cavity was prepared.
For canal length determination, #10 K-type (Perfect, China) hand files were used, and the working length was determined with an electronic apex locator (Woodpecker, Endo Radar Pro, China) and confirmed radiologically.
Root canal preparation was performed using an endodontic motor (Woodpecker, Endo Radar Pro, China) and a nickel-titanium rotary instrument system (Scope Endodontic System, Turkey) at a speed of 300 rpm and a torque of 2 N/cm. Apical preparation was completed to a size three larger. During shaping, at the point where apical resistance was encountered, excessive torsional loading was prevented by removing the files from the canal, cleaning the debris from the files, and irrigating the root canals.
During the shaping process, the root canals were rinsed with 2 ml of 2.5% NaOCl after each file change and recapitulated with a #10K file. After the root canal preparation procedure was completed, each canal was rinsed with 5 ml of 2.5% NaOCl, and the NaOCl solution was activated using an endoactivator in three 20-second cycles. 5 ml of distilled water was applied to remove NaOCl residues from the canal. Then, 2 ml of 17% EDTA (Endo-Solution, Cerkamed, Stalowa Wola, Poland) was applied for 1 minute. To neutralize the EDTA residues, each canal was finally irrigated with 5 ml of distilled water.
Irrigation procedures were performed with needles of different designs, each 30 G, for three different groups:
For group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland) was used, For group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey) was used, For group 3, a closed-ended double orifice irrigation needle (Double Sideport, Raito, China) was used.
The irrigation needles were used 2 mm shorter than the working length. The root canals were shaped using appropriate paper points (Meta Biomed, Korea). The root canals were filled using the lateral condensation technique with gutta-percha (Diadent Group International, Canada) and epoxy resin-based root canal paste (Dentac, Turkey). The permanent restoration was completed with light-curing composite (Coltene Whaledent Brilliant Ng, Switzerland), and occlusal adjustment was checked. Patients were prescribed 400 mg of ibuprofen and advised to use it when absolutely necessary.Evaluation of Postoperative Pain Patients were given a postoperative pain assessment form that included a visual analog scale (VAS) to evaluate their postoperative pain levels. Patients were informed about the topic and asked to record their pain levels and analgesic usage on the provided form at 6, 24, 48, 72 hours, and on the 7th day. Patients were called for a follow-up session one week later, and the given forms were collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: IrrigationFor group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland)Raito, China) |
| Group 2 | Experimental | Procedure: IrrigationFor group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey) |
| Group 3 | Experimental | Procedure: IrrigationFor group 3,a closed-ended double orifice irrigation needle (Double Sideport, Raito, China) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy patients ranging between 18 and 65 years in age,
- Patients with preoperative pain score ranging from moderate to severe (4-10) on a visual analog scale (VAS, 0-10)
- Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (14 listed)
- Patients with systemic diseases,
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 designs, each 30 G, for three different groups | Procedure or surgery | Group 1, Group 2, Group 3 |
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 23 Jul 2025.
- Derived from this study: PubMed 41501119Yersel A, Kirici D. The effect of the design of the irrigation needle used during endodontic treatment on postoperative pain: a randomize clinical trial. Sci Rep. 2026 Jan 7;16(1):4452. doi: 10.1038/s41598-025-34420-6.
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.
Damla Kırıcı, Associate Prof study chair
Akdeniz University
Damla Kırıcı, ASSOCİATE PROF study chair
AkdenizUniversity
DAMLA KIRICI, ASSOCİATE PROF study chair
AKDENİZ UNİVERSİTY
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 Lower Molars With Irreversible Pulpitis, 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 3 inclusion and 14 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 23 Jul 2025. 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?
On the ClinicalTrials.gov record for NCT07080918, which also lists 1 linked publication.
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 23 Jul 2025.