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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).

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 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.

Turkey (Türkiye)1 site
  • AkdenizUniversity

    Antalya

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07080918
Study groupRoleWhat they receive
Group 1ExperimentalFor group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland)Raito, China)
Receives: Procedure: Irrigation
Group 2ExperimentalFor group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey)
Receives: Procedure: Irrigation
Group 3ExperimentalFor 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.

  1. 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.

  1. First posted23 Jul 2025
  2. Study start1 Jan 2023
  3. Primary completion1 Jan 2024
  4. Study completion1 Aug 2024

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
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
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

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.

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