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CompletedNCT07355816EDRCD-PPUpdated Jan 21, 2026

Effect of Different Root Canal Disinfection Procedures on Postoperative Pain

An interventional study of Conventional Needle Irrigation and Passive Ultrasonic Irrigation in Pain, Postoperative, sponsored by Cumhuriyet University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Cumhuriyet University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2023, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This clinical study evaluated the effects of different root canal disinfection procedures on postoperative pain. Patients requiring root canal treatment received one of several disinfection methods. Postoperative pain was assessed at 6,24, 48, 72 hours and on the 7th day using a standard pain scale. The aim of the study was to identify which method resulted in the least discomfort. Participation involved a single treatment session and short-term follow-up for pain measurement.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • Root Canal Therapy,Disinfection Methods
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Cumhuriyet University is the lead sponsor of 128 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Systemically healthy individuals between the ages of 18 and 65,
  • Adequate mouth opening,
  • Asymptomatic devitaled mandibular premolar with a single root and single canal,
  • Negative response to cold and electric pulp tests and no bleeding at the pulp chamber opening,
  • Able to provide rubber dam isolation,
  • Presence of opposing teeth.

Exclusion criteria

Exclusion criteria

  • Presence of mental or psychiatric disorders,
  • Allergic diseases,
  • Use of painkillers within 12 hours or antibiotics within 1 week before the procedure,
  • Swelling, palpation/percussion pain, or sinus tract before treatment,
  • Presence of a periodontal pocket greater than 3 mm in diameter on the involved tooth,
  • Presence of a periapical radiolucency greater than 5 mm in diameter associated with the involved tooth,
  • Initiation of root canal treatment,
  • Irreparable material loss, root fracture, or crack,
  • Severe mobility,
  • Open apex,
  • Severe root canal calcification,
  • Internal or external resorption,
  • Bruxism,
  • Complaints of pain elsewhere in the mouth or in a tooth,
  • Being pregnant or breastfeeding.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    conventional needle irrigation

    Conventional needle irrigation(CNI) Group: A total of 6 mL of 2.5% NaOCl was delivered in three cycles using a 31-gauge irrigation needle positioned 2 mm short of the working length. Each cycle lasted 20 seconds, followed by a 20-second waiting period. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic acid(EDTA) (Imicryl Dental, Konya, Türkiye) was applied for 1 minute, followed by another 1-minute waiting period, and finally 2 mL of distilled water was used as the final rinse.

    Procedure: Conventional Needle Irrigation

  • Experimental
    Passive Ultrasonic Irrigation Group

    Passive ultrasonic irrigation(PUI) Group: Passive ultrasonic activation was performed with an ultrasonic device (Ultra X, Eighteeth, Changzhou, China) using a 20/.02 tip during the waiting periods used in the CNI group. The ultrasonic tip was positioned 2 mm short of the working length and activated vertically with 2-3 mm strokes without contacting the canal walls.

    Procedure: Passive Ultrasonic Irrigation

  • Experimental
    Sonic Irrigation Group

    Sonic irrigation(SI) Group: Sonic activation was performed using a polymer tip (Dentsply Tulsa Dental Specialties) loosely fitted into the canal and placed 2 mm short of the working length during the waiting periods used in the CNI group. The tip was activated by vertical in-and-out motion to induce sonic agitation.

    Procedure: Sonic Irrigation

  • Experimental
    KTP Laser Disinfection Group

    Potassium titanyl phosphate(KTP) Laser Group: In this group, after shaping was completed, the final irrigation procedure was carried out as in the CNI group. Following irrigation, the root canals were dried with sterile paper points at the working length. Then, KTP laser irradiation (SMARLITE D, DEKA laser system, Calenzano FI, Italy) was applied in a pulsed mode at 1.5 W power (Ton: 20 ms, Toff: 50 ms). A 200 µm fiber tip attached to the handpiece was inserted 1 mm short of the working length and moved coronally in a spiral motion for 5 seconds. After each 5-second irradiation, a 20-second interval was allowed, and the process was repeated five times. Laser safety protocols were strictly followed, and protective goggles were used by the operator, assistant, and patient.

    Procedure: KTP Laser Disinfection

Interventions

  • ProcedureConventional Needle Irrigation

    Root canals will be irrigated using a conventional syringe and needle technique with standard irrigant solutions. This method relies solely on manual delivery without activation devices.

  • ProcedurePassive Ultrasonic Irrigation

    Root canals will be irrigated using passive ultrasonic activation, which uses ultrasonic energy to improve irrigant effectiveness and reduce microbial load beyond manual techniques.

  • ProcedureSonic Irrigation

    Root canals will be irrigated using a sonic activation device (e.g., EndoActivator) to enhance irrigant penetration and bacterial elimination compared to conventional irrigation.

  • ProcedureKTP Laser Disinfection

    Root canals will be disinfected using a KTP laser following standard irrigation protocols. Laser application aims to provide enhanced antimicrobial effects not achievable with conventional or activated irrigation methods.

06

What researchers measure

Primary outcomes

  1. Postoperative Pain Intensity

    Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 100, where 0 indicates no pain and 100 indicates the worst pain imaginable; higher scores indicate greater pain severity

    Time frame: 6, 12, 24, 48, and 72 hours after root canal treatment

07

Study locations

1 site
  • Faculty of Dentistry, Cumhuriyet University, Sivas
    Sivas, 58000, Turkey (Türkiye)
08

References and documents

Study documents

  • Protocol and informed consent form · Dec 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07355816
Lead sponsor
Cumhuriyet University
Responsible party
İbrahim AKDENİZ (Specialist dentist / Endodontist, Cumhuriyet University) — Principal investigator
First posted
Jan 21, 2026
Start date
Jun 13, 2023
Primary completion
Nov 11, 2024
Completion
Nov 11, 2024
Last update
Jan 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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