NCT07080918

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 15, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

root canal treatment, conventional needle irrigation, irrigation needle design, postoperative pain

Outcome Measures

Primary Outcomes (1)

  • Assessment of postoperative pain with VAS after root canal treatment

    6, 24, 48, 72 hours, and on the 7th day

Study Arms (3)

Group 1

EXPERIMENTAL

For group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland)Raito, China)

Procedure: Irrigation

Group 2

EXPERIMENTAL

For group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey)

Procedure: Irrigation

Group 3

EXPERIMENTAL

For group 3,a closed-ended double orifice irrigation needle (Double Sideport, Raito, China)

Procedure: Irrigation

Interventions

IrrigationPROCEDURE

Irrigation procedures were performed with needles of different designs, each 30 G, for three different groups

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AkdenizUniversity

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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. doi: 10.1038/s41598-025-34420-6. Online ahead of print.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Damla Kırıcı, Associate Prof

    Akdeniz University

    STUDY CHAIR
  • Damla Kırıcı, ASSOCİATE PROF

    AkdenizUniversity

    STUDY CHAIR
  • DAMLA KIRICI, ASSOCİATE PROF

    AKDENİZ UNİVERSİTY

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Damla Kırıcı

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 23, 2025

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

August 1, 2024

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations