Endodontic DiseaseNCT06741592
Postoperative Pain in Endodontic Therapy
A study testing EDDY Group and PUI Group in people with Endodontic Disease and Postoperative Pain, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the change in postoperative pain in mandibular premolar and first molar teeth with asymptomatic apical periodontitis when using EDDY and passive ultrasonic irrigation activation methods. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Postoperative Pain
- What is being tested?
- EDDY Group and PUI Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 5 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 55 years, medically healthy, and free from systemic diseases.
- Patients without pregnancy or breastfeeding status.
- Patients diagnosed with asymptomatic apical periodontitis confirmed through radiographic and clinical examination.
- Patients not having a regular intake of analgesic or anti-inflammatory drugs within the last 12 hours.
- Patients lacking a history of drug allergies.
- Teeth free from calcifications, resorptions, periodontal problems, incomplete root development, a history of endodontic treatment, traumatic occlusion, or severe coronal destruction.
- Teeth with a root canal curvature of 5° or less.
- Mandibular premolars and first molars.
Who cannot join
- Teeth where the apical area could not be reached with a #8K file.
- Teeth with an apical diameter larger than #20K file.
- Patients with a Periapical Index (PAI) score of 1 or 2.
- Teeth having extra canals.
- Teeth requiring a second local anesthesia during treatment.
- Teeth where a file fractured within the canal during preparation.
Show all 10Show fewer
- Vital teeth.
- Patients reporting preoperative pain.
- Teeth showing clinical symptoms such as percussion or palpation sensitivity.
- Teeth with persistent purulent discharge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Irrigation Activation Methods Preferred During Root Canal Treatment On Postoperative Pain: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the change in postoperative pain in mandibular premolar and first molar teeth with asymptomatic apical periodontitis when using EDDY and passive ultrasonic irrigation activation methods.
The null hypothesis is: "There is no difference in postoperative pain after root canal treatment between the irrigation activation systems in mandibular first molars and premolar teeth."
- Conditions
- Endodontic Disease, Postoperative Pain
- Being tested
- EDDY Group, PUI Group
- Keywords
- EDDY, Irrigation Activation, Passive Ultrasonic Irrigation
- Medical subject headings
- Dental Pulp Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDDY GroupDevice
The EDDY activation of the irrigation solutions used is performed to achieve root canal disinfection and enhance antibacterial effectiveness once the root canal preparation is completed.
PUI GroupDevice
The passive ultrasonic activation of the irrigation solutions used is performed to achieve root canal disinfection and enhance antibacterial effectiveness once the root canal preparation is completed.
| Study group | Role | What they receive |
|---|---|---|
| EDDY Group | Experimental | The effect of the EDDY device, preferred for root canal irrigation activation, on postoperative pain formation Receives: Device: EDDY Group |
| PUI Group | Experimental | The effect of the passive ultrasonic activation method, preferred for root canal irrigation activation, on postoperative pain formation Receives: Device: PUI Group |
| Control Group | No intervention | Root canal treatment performed with conventional irrigation without the use of any activation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Measured: 8th hour
Postoperative Pain
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Measured: 12th hour
Postoperative Pain
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Measured: 24th hour
Postoperative Pain
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Measured: 48th hour
Postoperative Pain
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start12 Feb 2024
- Primary completion4 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seca MUTLU, Ordu University
- Investigators
- Seca MUTLU, Principal investigator, Ordu University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741592
- Sponsor's protocol ID
- ODU-MUTLU-001
- Status last verified
- Nov 2024
- First submitted
- 12 Dec 2024
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Irrigation Activation Methods Preferred During Root Canal Treatment On Postoperative Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06741592
- Acronym / sponsor ID
- ODU-MUTLU-001
- Conditions
- Endodontic Disease, Postoperative Pain
- Keywords
- EDDY, Irrigation Activation, Passive Ultrasonic Irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 19 Dec 2024 (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 goal of this clinical trial is to evaluate the change in postoperative pain in mandibular premolar and first molar teeth with asymptomatic apical periodontitis when using EDDY and passive ultrasonic irrigation activation methods.
The null hypothesis is: "There is no difference in postoperative pain after root canal treatment between the irrigation activation systems in mandibular first molars and premolar teeth."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDDY Group | Experimental | Device: EDDY GroupThe effect of the EDDY device, preferred for root canal irrigation activation, on postoperative pain formation |
| PUI Group | Experimental | Device: PUI GroupThe effect of the passive ultrasonic activation method, preferred for root canal irrigation activation, on postoperative pain formation |
| Control Group | No intervention | –Root canal treatment performed with conventional irrigation without the use of any activation method |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients aged between 18 and 55 years, medically healthy, and free from systemic diseases.
- Patients without pregnancy or breastfeeding status.
- Patients diagnosed with asymptomatic apical periodontitis confirmed through radiographic and clinical examination.
- Patients not having a regular intake of analgesic or anti-inflammatory drugs within the last 12 hours.
- Patients lacking a history of drug allergies.
Key exclusion criteria (10 listed)
- Teeth where the apical area could not be reached with a #8K file.
- Teeth with an apical diameter larger than #20K file.
- Patients with a Periapical Index (PAI) score of 1 or 2.
- Teeth having extra canals.
- Teeth requiring a second local anesthesia during treatment.
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 |
|---|---|---|
| EDDY GroupThe EDDY activation of the irrigation solutions used is performed to achieve root canal disinfection and enhance antibacterial effectiveness once the root canal preparation is completed. | Device | EDDY Group |
| PUI GroupThe passive ultrasonic activation of the irrigation solutions used is performed to achieve root canal disinfection and enhance antibacterial effectiveness once the root canal preparation is completed. | Device | PUI Group |
Primary outcome
Postoperative Pain
Time frame: 8th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Postoperative Pain
Time frame: 12th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Postoperative Pain
Time frame: 24th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Postoperative Pain
Time frame: 48th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
Postoperative Pain
Time frame: 7th day
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
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 19 Dec 2024.
- 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.
Seca MUTLU principal investigator
Ordu University, Faculty of Dentistry, Department of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDDY Group and PUI Group in people with Endodontic Disease and Postoperative Pain, run by Ordu 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 8 inclusion and 10 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 19 Dec 2024. 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?
Postoperative Pain (time frame: 8th hour). The study lists 5 primary outcomes in all. 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 19 Dec 2024.