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Status unknownNCT04892355Updated Feb 15, 2022

Postoperative Pain After İntracanal Procedures

An interventional study of Root canal irrigation in Endodontically Treated Teeth, sponsored by Afyonkarahisar Health Sciences University. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Afyonkarahisar Health Sciences University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Post-operative pain values of the participants will be recorded and evaluated with the VAS scale.

Postoperative pain values of the techniques will be compared with statistical evaluation.

Read the detailed description

Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Materials and Methods: The study will be carried out on 140 patients with molar teeth diagnosed with irreversible pulpitis. After the root canal preparation is completed, the patients will be divided into 4 groups according to the irrigation activation system; Conventional syringe irrigation (CSI), EDDY, EndoActivator (EA) and Xp-endo Finisher (XPF). After the irrigation process is completed, the root canals will be filled using gutta-percha and canal sealer and the treatment will be completed in one session. Pain values at 6, 24, 48, 72 hours and 7 days after treatment will be evaluated at a 0.05% significance level using the Kruskal-Wallis test.

02

Conditions studied

  • Endodontically Treated Teeth

Keywords

  • EDDY
  • EndoActivatör
  • Xp-endo Finisher
  • Postoperative pain
03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's planned enrollment of 140 is above the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Afyonkarahisar Health Sciences University is the lead sponsor of 107 studies on the registry; 33 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy patients ranging between 18 and 60 years in age
  • Patients that experienced moderate-to-severe pain represented on a visual analogue scale (VAS)
  • Maxillar and Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis

Exclusion criteria

Exclusion Criteria:

  • Any systemic disease and pregnancy in the patient
  • Having used analgesic-anti-inflammatory in the last 12 hours and cortisone for the last 6 months
  • The patient has bruxism
  • Teeth with severe damage
  • Teeth with calcified canals
  • Teeth with pain to percussion
  • Teeth with periapical radiolucency
  • Teeth with root resorption
  • Teeth with an immature / open apex
  • Teeth with previous RCT
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Conventional Syringe Irrigation Group

    During the final irrigation procedure, a 30 - G side vented needle was placed 2 mm shorter than the working length and was applied without agitation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

    Device: Root canal irrigation

  • Experimental
    Xp Endo Finisher Group

    Xp Endo Finisher file was used with VDW Silver (VDW) endomotor at 800 rpm speed and 1 Ncm torque according to the manufacturer's instructions. The Xp Endo Finisher file was placed in the canal, 2 mm shorter than the working length, and was used with slow movements of 7-8 mm amplitude in the canal during activation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

    Device: Root canal irrigation

  • Experimental
    EDDY Group

    An EDDY tip of size 25/04 was used for sonic activation. The EDDY was placed in the duct 2 mm shorter than the working length and the activation process was performed with slow movements with an amplitude of 2-4 mm. In the irrigation process, 5 mL of 2.5% NaOCI was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

    Device: Root canal irrigation

  • Experimental
    Endoactivator Group

    Medium Endoactivator tip of 25 / .04 size was used for irrigation activation. Medium type was placed in the canal 2 mm shorter than the working length and activation was performed by making short strokes of 2-3 mm. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.

    Device: Root canal irrigation

Interventions

  • DeviceRoot canal irrigation

    Devices used during root canal irrigation

    Also known as: EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-

06

What researchers measure

Primary outcomes

  1. Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial

    Preoperative pain of the patients before the treatment was recorded with the VAS scale. Pain levels were classified as 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain .After the treatment of the patients, a pain assessment form was given to the patient in order to evaluate the postoperative pain. Patients were asked to mark their pain levels on the VAS scale. The marking procedure was taught to the patients by a blinded researcher from the groups. When the patients came to the control appointment, VAS scales were collected and the data were analyzed.

    Time frame: one week(7 days)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04892355
Lead sponsor
Afyonkarahisar Health Sciences University
Responsible party
Yahya Güven (Assist. Prof. Dr. Yahya GÜVEN, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
May 19, 2021
Start date
Aug 6, 2022 (estimated)
Primary completion
Oct 6, 2022 (estimated)
Completion
Nov 6, 2022 (estimated)
Last update
Feb 15, 2022

Study contacts

yahya güven
Contact
yahyaguven52@outlook.com
05314599583
yahya güven
principal investigator · Afyonkarahisar Health Sciences University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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