Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment

Sponsor

Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT04262245

Collaborator

(none)

100

Enrollment

Location

Arm

32.3

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Traditional Irrigation Device: Xp-endo Finisher (XPF) Device: Passive Ultrasonic Irrigation Device: EndoActivator	N/A

Detailed Description

Vaious irrigation activation techniques have been used endodontic practice. These techniques are used to improve the activity of solutions. The selected techniques in this study are accepted as efficient methods for activation. However, postoperative pan is an important issue for clinicians. Thus, Traditional Irrigation (GI), Xp-endo Finisher (XPF), Passive Ultrasonic Irrigation (PUI), EndoActivator (EA) techniques will be used for irrigation activation. All techniques remove hard and soft tissue remnants successfully. The clinician expect to eliminate the postoperative pain. Therefore, a possible increase in pain due to activation technique may limit the use of these methods. The pain scores will be measured using the scale and statistically analyzed.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment

Actual Study Start Date :

Jan 5, 2017

Actual Primary Completion Date :

Sep 14, 2019

Actual Study Completion Date :

Sep 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: irrigation activation method 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 Irrigation irrigation with syringe Device: Xp-endo Finisher (XPF) irrigation activation file Device: Passive Ultrasonic Irrigation irrigation activation method Device: EndoActivator irrigation activation method

Arm

Intervention/Treatment

Other: irrigation activation method

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 Irrigation

irrigation with syringe

Device: Xp-endo Finisher (XPF)

irrigation activation file

Device: Passive Ultrasonic Irrigation

irrigation activation method

Device: EndoActivator

irrigation activation method

Outcome Measures

Primary Outcome Measures

Incidence of postoperative after endodontic treatment [0-48 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

nonvital tooth
single rooted tooth

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bülent Ecevit University, Faculty of Dentistry	Zonguldak		Turkey

Sponsors and Collaborators

Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mustafa Murat Koçak, Associate professor, Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT04262245

Other Study ID Numbers:

2017-100-04/10

First Posted:

Feb 10, 2020

Last Update Posted:

Feb 10, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Feb 10, 2020