Postoperative PainNCT04262245
Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
A study testing Traditional Irrigation, Xp-endo Finisher (XPF) and Passive Ultrasonic Irrigation in people with Postoperative Pain, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Traditional Irrigation, Xp-endo Finisher (XPF) and Passive Ultrasonic Irrigation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2017to 14 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nonvital tooth
- single rooted tooth
Who cannot join
- tooth not requiring root canal treatment
- patients under 18 years old
- vital tooth
- tooth having more than 1 canal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bülent Ecevit University, Faculty of Dentistry
Zonguldak
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Traditional Irrigation, Xp-endo Finisher (XPF), Passive Ultrasonic Irrigation, EndoActivator
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional IrrigationProcedure or surgery
irrigation with syringe
Xp-endo Finisher (XPF)Device
irrigation activation file
Passive Ultrasonic IrrigationDevice
irrigation activation method
EndoActivatorDevice
irrigation activation method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Traditional Irrigation; Device: Xp-endo Finisher (XPF); Device: Passive Ultrasonic Irrigation; Device: EndoActivator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start5 Jan 2017
- Primary completion14 Sep 2019
- Study completion14 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Murat Koçak, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262245
- Sponsor's protocol ID
- 2017-100-04/10
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Irrigation Activation Techniques on Postoperative Pain After Endodontic Treatment
- ClinicalTrials.gov ID
- NCT04262245
- Acronym / sponsor ID
- 2017-100-04/10
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 14 Sep 2019 (actual)
- Study completion
- 14 Sep 2019 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irrigation activation method | Other | Procedure: Traditional Irrigation, Device: Xp-endo Finisher (XPF), Device: Passive Ultrasonic Irrigation, Device: EndoActivatorIrrigation 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nonvital tooth
- single rooted tooth
Key exclusion criteria (4 listed)
- tooth not requiring root canal treatment
- patients under 18 years old
- vital tooth
- tooth having more than 1 canal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Irrigationirrigation with syringe | Procedure or surgery | irrigation activation method |
| Xp-endo Finisher (XPF)irrigation activation file | Device | irrigation activation method |
| Passive Ultrasonic Irrigationirrigation activation method | Device | irrigation activation method |
| EndoActivatorirrigation activation method | Device | irrigation activation method |
Primary outcome
Incidence of postoperative after endodontic treatment
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Irrigation, Xp-endo Finisher (XPF) and Passive Ultrasonic Irrigation in people with Postoperative Pain, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative after endodontic treatment (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.