NCT04262245

Brief Summary

The aim of this study is to evaluate the effect of different irrigation activation methods on postoperative pain using visual analog scale (VAS) using Xp-endo Finisher, EndoActivator and Passive ultrasonic irrigation activation techniques with traditional irrigation method. In this study, Traditional Irrigation (GI), Xp-endo Finisher (XPF), Passive Ultrasonic Irrigation (PUI), EndoActivator (EA) techniques will be used for irrigation activation. Twenty-five maxillary or mandibular single root and canal-shaped nonvital teeth will used in each group. Root canals will be prepared with TF-Adaptive system. Four different activation techniques will be applied during final irrigation. The canal treatments will be completed in one stage and postoperative pain analysis will be taken with VAS (Visual Analog Scale) scale after 12-24-48 hours. Statistical analysis will be performed with Mann Whitney-U test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable postoperative-pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

February 5, 2020

Last Update Submit

February 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative after endodontic treatment

    The incidence and severity of pain will be evaluated by using visual analog scale (VAS). The severity of pain varies between 0 to 10, in which 0 means no pain, whislt 10 means unbearable pain.

    0-48 hours

Study Arms (1)

irrigation activation method

OTHER

Irrigation activation is a crucial stage of root canal treatment. Therefore, the effect of activation methods on post treatment is an important fact for the comfort of patients.

Procedure: Traditional IrrigationDevice: Xp-endo Finisher (XPF)Device: Passive Ultrasonic IrrigationDevice: EndoActivator

Interventions

irrigation with syringe

irrigation activation method

irrigation activation file

irrigation activation method

irrigation activation method

irrigation activation method

irrigation activation method

irrigation activation method

Eligibility Criteria

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

You may qualify if:

  • nonvital tooth
  • single rooted tooth

You may not qualify if:

  • tooth not requiring root canal treatment
  • patients under 18 years old
  • vital tooth
  • tooth having more than 1 canal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bülent Ecevit University, Faculty of Dentistry

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 10, 2020

Study Start

January 5, 2017

Primary Completion

September 14, 2019

Study Completion

September 14, 2019

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations