Back to resultsComparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Traditional Irrigation
Xp-endo Finisher (XPF)
Passive Ultrasonic Irrigation
EndoActivator
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Bülent Ecevit University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
irrigation activation method
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04262245
First Posted
February 5, 2020
Last Updated
February 7, 2020
Sponsor
Bulent Ecevit University
1. Study Identification
Unique Protocol Identification Number
NCT04262245
Brief Title
Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
Official Title
Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
September 14, 2019 (Actual)
Study Completion Date
September 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
irrigation activation method
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional Irrigation
Intervention Description
irrigation with syringe
Intervention Type
Device
Intervention Name(s)
Xp-endo Finisher (XPF)
Intervention Description
irrigation activation file
Intervention Type
Device
Intervention Name(s)
Passive Ultrasonic Irrigation
Intervention Description
irrigation activation method
Intervention Type
Device
Intervention Name(s)
EndoActivator
Intervention Description
irrigation activation method
Primary Outcome Measure Information:
Title
Incidence of postoperative after endodontic treatment
Description
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.
Time Frame
0-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bülent Ecevit University, Faculty of Dentistry
City
Zonguldak
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
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