Postoperative PainNCT06711029
Effect of Passive Ultrasonic Irrigation Activation Cycle on Postoperative Pain
A study testing Conventional needle irrigation, Passive Ultrasonic Irrigation with 3*20 sn and Passive Ultrasonic Irrigation with 6*10 sn in people with Postoperative Pain, run by Esin Özlek.
Trial summary
One of the most important goals of root canal treatment is to eliminate bacteria from infected canals. However, conventional irrigation methods combined with mechanical preparation applied during root canal treatment may not be sufficient for optimal disinfection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Conventional needle irrigation, Passive Ultrasonic Irrigation with 3*20 sn and Passive Ultrasonic Irrigation with 6*10 sn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons between the ages of 18 and 45 years
- Single-rooted and single-canal mandibular premolars diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Different Duration and Number of Passive Ultrasonic Irrigation Activation Cycles on Postoperative Pain in Teeth with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
One of the most important goals of root canal treatment is to eliminate bacteria from infected canals. However, conventional irrigation methods combined with mechanical preparation applied during root canal treatment may not be sufficient for optimal disinfection. Various studies have shown that there are areas in the root canal that cannot be reached during chemomechanical shaping. One of the most popular techniques developed to deliver irrigation solutions to these areas is the Passive Ultrasonic Irrigation (PUI) technique, which provides good efficiency in terms of cleaning the root canal system. Activation of NAOCI with ultrasonic systems in the final irrigation significantly reduces the amount of microorganisms in the canal. Although the use of PUI in the final irrigation increases the effectiveness of irrigation solutions and enables the solutions to reach the apical third of the root canal, it causes extrusion of solutions into periapical tissues, albeit in small amounts, due to the positive apical pressure it creates during irrigation, and this causes postoperative pain. Postoperative pain is an undesirable but frequently encountered condition after endodontic treatment. During root canal treatment, extrusion of irrigation solutions or debris from the apex, mechanical, chemical or microbial factors can cause postoperative pain. In one study, the incidence of postoperative pain after endodontic treatment was reported to vary from 3% to 58%. Although the most effective is not yet fully known, when the literature is reviewed, different durations and cycles have been used for PUI. The change in the number of PUI cycles increases the microflow in the root canal, which may increase irrigation extrusion from the apical region and affect postoperative pain. Although many results have been reported in studies comparing the effect of final activation with Passive Ultrasonic Irrigation on postoperative pain with another technique, the activation cycle with PUI was determined as 3 times and 20 seconds each time, and this cycle order remained the same most of the time. Since there is no study in which the differences between cycles in activation with PUI affected postoperative pain, in this study the irrigation solution will be activated with PUI 3 times for 20 seconds and 6 times for 10 seconds, and the postoperative pain created by these two cycle orders will be compared.
Read the detailed description
The study is planned to be conducted on 60 patients between the ages of 18-45 who were diagnosed and followed up at the Endodontics Clinic of the Faculty of Dentistry of Van Yuzuncu Yil University. Patients with no systemic disease, diagnosed with irreversible pulpitis, single-rooted and single-canal lower premolar teeth will be included in the case group. Patients with resorption and calcification at the roots of their teeth, incomplete root development, pregnant and breastfeeding, those who have taken analgesics or anti-inflammatory drugs in the last 12 hours, those who have used antibiotics in the last month, and those who cannot use a rubber dam in root canal treatment will not be included in the study. After obtaining the consent form from the patients, local anesthesia (Ultracain DS Fort, Hoechst-Marian Roussel, Frankfurt, Germany) will be applied to the tooth to be treated with root canal treatment. The access cavity will be opened with diamond burs under rubber dam isolation. The working length will be determined using a #10 K file (Mani Inc, Tochigi, Japan) and an electronic apex locator (Propex Pixi, Dentsply Maillefer, Switzerland). The root canals will be shaped to a size 40/0.06 using NiTI rotary files (ProTaper Next; Dentsply Sirona) at 300 rpm and 2 Ncm according to the manufacturer's instructions. The patients will be divided into 3 groups according to the final irrigation activation protocol for root canal treatment: Group 1: Control group. In the final irrigation, NaOCI will be applied with needle irrigation for a total of 60 s. Group 2: PUI 3*20 s. In the final irrigation, NaOCI will be applied with PUI for 3*20 s for a total of 60 s. Group 3: PUI 6*10 s. In the final irrigation, NaOCI will be applied for 60 seconds in total with PUI for 6*10 seconds. 5.25% NaOCI and 17% EDTA will be used as irrigation solution during the shaping process. NaviTip irrigation needle (30-G; Ultradent Products Inc, South Jordan, USA) will be used in the irrigation process during shaping. After the activation process is completed, the canals will be rinsed with distilled water as the final irrigation and the root canals will be filled with gutta percha and Adseal (Meta Biomed, Cheongju, North Korea) root canal sealer using the single cone method. The teeth will be restored with composite. Patients will be prescribed 400 mg ibuprofen anti-inflammatory medication to use in case of severe pain. The pain levels of the patients before and after the procedure will be evaluated with the VAS (Visual Analogue Scale) pain scale. Patients will be given a 10 cm paper ruler to record their pain levels at 6, 12, 24, 48, 72 hours and 1 week. Patients will be instructed on how to score their pain levels and will be asked to mark their pain levels on the ruler at the specified hours. At the end of the 1 week period, the rulers will be collected from the patients and the data will be statistically analyzed and interpreted.
- Conditions
- Postoperative Pain
- Being tested
- Conventional needle irrigation, Passive Ultrasonic Irrigation with 3*20 sn, Passive Ultrasonic Irrigation with 6*10 sn
- Keywords
- Postoperative Pain, Passive ultrasonic irrigation, Activation cycles
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional needle irrigationOther
Conventional needle irrigation method was applied. As a final irrigation, 6 ml NaOCl was applied with 60 seconds of needle irrigation followed by 60 seconds of rest.
Passive Ultrasonic Irrigation with 3*20 snOther
In the final irrigation, 6 ml (3×2 ml) NaOCl was activated by PUI for 20 seconds in 3 cycles (60 seconds total). Before each cycle, 2 ml of NaOCl solution was refreshment.
Passive Ultrasonic Irrigation with 6*10 snOther
For the final irrigation, 6 ml (6×1 ml) NaOCl was activated with PUI for 10 seconds in 6 cycles (60 seconds total). Before each cycle, 1 ml of NaOCl solution was refreshment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | In the final irrigation, 6 ml of 5.252% NaOCI will be applied with needle irrigation for a total of 60 seconds. Receives: Other: Conventional needle irrigation |
| Passive Ultrasonic Irrigation 3*20 sec | Active comparator | In the final irrigation, 6 ml of 5.25% NaOCI will be applied as 3*20 seconds with PUI for a total of 60 seconds. Receives: Other: Passive Ultrasonic Irrigation with 3*20 sn |
| Passive Ultrasonic Irrigation 6*10 sec | Active comparator | In the final irrigation, 6 ml of 5.25% NaOCI will be applied as 6*10 seconds with PUI for a total of 60 seconds. Receives: Other: Passive Ultrasonic Irrigation with 6*10 sn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score Scala
Postoperative pain will be assessed with a visual analog score after endodontic treatment. Scores will be given between 0-10. A score of '0' means no pain, a score of '10' means very severe pain. The higher the score, the higher the pain level.
Measured: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion10 Feb 2025 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into 3 groups according to the final irrigation activation method; Group 1: Control Group, Group 2: Passive Ultrasonic Irrigation 3\*20 sec, Group 3: Passive Ultrasonic Irrigation 6\*10 sec.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esin Özlek
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Sponsor-investigator, Esin Özlek, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711029
- Sponsor's protocol ID
- 03/15.11.2023
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Apical Positive and Negative Pressure Irrigation Methods on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Aug;44(8):1210-1215. doi: 10.1016/j.joen.2018.04.019. Epub 2018 Jun 20.
PubMed 29935873Estevez R, Conde AJ, Valencia de Pablo O, de la Torre F, Rossi-Fedele G, Cisneros R. Effect of Passive Ultrasonic Activation on Organic Tissue Dissolution from Simulated Grooves in Root Canals Using Sodium Hypochlorite with or without Surfactants and EDTA. J Endod. 2017 Jul;43(7):1161-1165. doi: 10.1016/j.joen.2017.01.041. Epub 2017 Apr 14.
PubMed 28416316Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
PubMed 27248848Ali A, Hashem AAR, Roshdy NN, Abdelwahed A. The Effect of Final Irrigation Agitation Techniques on Postoperative Pain after Single Visit Root Canal Treatment of Symptomatic Irreversible Pulpitis: A Randomised Clinical Trial. Eur Endod J. 2023 May;8(3):187-193. doi: 10.14744/eej.2022.39200.
PubMed 37257031
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Duration and Number of Passive Ultrasonic Irrigation Activation Cycles on Postoperative Pain in Teeth with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06711029
- Acronym / sponsor ID
- 03/15.11.2023
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Passive ultrasonic irrigation, Activation cycles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Esin ÖzlekUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 2 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.
One of the most important goals of root canal treatment is to eliminate bacteria from infected canals. However, conventional irrigation methods combined with mechanical preparation applied during root canal treatment may not be sufficient for optimal disinfection. Various studies have shown that there are areas in the root canal that cannot be reached during chemomechanical shaping. One of the most popular techniques developed to deliver irrigation solutions to these areas is the Passive Ultrasonic Irrigation (PUI) technique, which provides good efficiency in terms of cleaning the root canal system. Activation of NAOCI with ultrasonic systems in the final irrigation significantly reduces the amount of microorganisms in the canal. Although the use of PUI in the final irrigation increases the effectiveness of irrigation solutions and enables the solutions to reach the apical third of the root canal, it causes extrusion of solutions into periapical tissues, albeit in small amounts, due to the positive apical pressure it creates during irrigation, and this causes postoperative pain. Postoperative pain is an undesirable but frequently encountered condition after endodontic treatment. During root canal treatment, extrusion of irrigation solutions or debris from the apex, mechanical, chemical or microbial factors can cause postoperative pain. In one study, the incidence of postoperative pain after endodontic treatment was reported to vary from 3% to 58%. Although the most effective is not yet fully known, when the literature is reviewed, different durations and cycles have been used for PUI. The change in the number of PUI cycles increases the microflow in the root canal, which may increase irrigation extrusion from the apical region and affect postoperative pain. Although many results have been reported in studies comparing the effect of final activation with Passive Ultrasonic Irrigation on postoperative pain with another technique, the activation cycle with PUI was determined as 3 times and 20 seconds each time, and this cycle order remained the same most of the time. Since there is no study in which the differences between cycles in activation with PUI affected postoperative pain, in this study the irrigation solution will be activated with PUI 3 times for 20 seconds and 6 times for 10 seconds, and the postoperative pain created by these two cycle orders will be compared.
Detailed description
The study is planned to be conducted on 60 patients between the ages of 18-45 who were diagnosed and followed up at the Endodontics Clinic of the Faculty of Dentistry of Van Yuzuncu Yil University. Patients with no systemic disease, diagnosed with irreversible pulpitis, single-rooted and single-canal lower premolar teeth will be included in the case group. Patients with resorption and calcification at the roots of their teeth, incomplete root development, pregnant and breastfeeding, those who have taken analgesics or anti-inflammatory drugs in the last 12 hours, those who have used antibiotics in the last month, and those who cannot use a rubber dam in root canal treatment will not be included in the study. After obtaining the consent form from the patients, local anesthesia (Ultracain DS Fort, Hoechst-Marian Roussel, Frankfurt, Germany) will be applied to the tooth to be treated with root canal treatment. The access cavity will be opened with diamond burs under rubber dam isolation. The working length will be determined using a #10 K file (Mani Inc, Tochigi, Japan) and an electronic apex locator (Propex Pixi, Dentsply Maillefer, Switzerland). The root canals will be shaped to a size 40/0.06 using NiTI rotary files (ProTaper Next; Dentsply Sirona) at 300 rpm and 2 Ncm according to the manufacturer's instructions. The patients will be divided into 3 groups according to the final irrigation activation protocol for root canal treatment: Group 1: Control group. In the final irrigation, NaOCI will be applied with needle irrigation for a total of 60 s. Group 2: PUI 3*20 s. In the final irrigation, NaOCI will be applied with PUI for 3*20 s for a total of 60 s. Group 3: PUI 6*10 s. In the final irrigation, NaOCI will be applied for 60 seconds in total with PUI for 6*10 seconds. 5.25% NaOCI and 17% EDTA will be used as irrigation solution during the shaping process. NaviTip irrigation needle (30-G; Ultradent Products Inc, South Jordan, USA) will be used in the irrigation process during shaping. After the activation process is completed, the canals will be rinsed with distilled water as the final irrigation and the root canals will be filled with gutta percha and Adseal (Meta Biomed, Cheongju, North Korea) root canal sealer using the single cone method. The teeth will be restored with composite. Patients will be prescribed 400 mg ibuprofen anti-inflammatory medication to use in case of severe pain. The pain levels of the patients before and after the procedure will be evaluated with the VAS (Visual Analogue Scale) pain scale. Patients will be given a 10 cm paper ruler to record their pain levels at 6, 12, 24, 48, 72 hours and 1 week. Patients will be instructed on how to score their pain levels and will be asked to mark their pain levels on the ruler at the specified hours. At the end of the 1 week period, the rulers will be collected from the patients and the data will be statistically analyzed and interpreted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be divided into 3 groups according to the final irrigation activation method; Group 1: Control Group, Group 2: Passive Ultrasonic Irrigation 3*20 sec, Group 3: Passive Ultrasonic Irrigation 6*10 sec.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional needle irrigationIn the final irrigation, 6 ml of 5.252% NaOCI will be applied with needle irrigation for a total of 60 seconds. |
| Passive Ultrasonic Irrigation 3*20 sec | Active comparator | Other: Passive Ultrasonic Irrigation with 3*20 snIn the final irrigation, 6 ml of 5.25% NaOCI will be applied as 3*20 seconds with PUI for a total of 60 seconds. |
| Passive Ultrasonic Irrigation 6*10 sec | Active comparator | Other: Passive Ultrasonic Irrigation with 6*10 snIn the final irrigation, 6 ml of 5.25% NaOCI will be applied as 6*10 seconds with PUI for a total of 60 seconds. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 45 years
- Single-rooted and single-canal mandibular premolars diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (6 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
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 |
|---|---|---|
| Conventional needle irrigationConventional needle irrigation method was applied. As a final irrigation, 6 ml NaOCl was applied with 60 seconds of needle irrigation followed by 60 seconds of rest. | Other | Control Group |
| Passive Ultrasonic Irrigation with 3*20 snIn the final irrigation, 6 ml (3×2 ml) NaOCl was activated by PUI for 20 seconds in 3 cycles (60 seconds total). Before each cycle, 2 ml of NaOCl solution was refreshment. | Other | Passive Ultrasonic Irrigation 3*20 sec |
| Passive Ultrasonic Irrigation with 6*10 snFor the final irrigation, 6 ml (6×1 ml) NaOCl was activated with PUI for 10 seconds in 6 cycles (60 seconds total). Before each cycle, 1 ml of NaOCl solution was refreshment. | Other | Passive Ultrasonic Irrigation 6*10 sec |
Primary outcome
Visual Analog Score Scala
Time frame: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.
Postoperative pain will be assessed with a visual analog score after endodontic treatment. Scores will be given between 0-10. A score of '0' means no pain, a score of '10' means very severe pain. The higher the score, the higher the pain level.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 29935873Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Apical Positive and Negative Pressure Irrigation Methods on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Aug;44(8):1210-1215. doi: 10.1016/j.joen.2018.04.019. Epub 2018 Jun 20.
- Background: PubMed 28416316Estevez R, Conde AJ, Valencia de Pablo O, de la Torre F, Rossi-Fedele G, Cisneros R. Effect of Passive Ultrasonic Activation on Organic Tissue Dissolution from Simulated Grooves in Root Canals Using Sodium Hypochlorite with or without Surfactants and EDTA. J Endod. 2017 Jul;43(7):1161-1165. doi: 10.1016/j.joen.2017.01.041. Epub 2017 Apr 14.
- Background: PubMed 27248848Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
- Background: PubMed 37257031Ali A, Hashem AAR, Roshdy NN, Abdelwahed A. The Effect of Final Irrigation Agitation Techniques on Postoperative Pain after Single Visit Root Canal Treatment of Symptomatic Irreversible Pulpitis: A Randomised Clinical Trial. Eur Endod J. 2023 May;8(3):187-193. doi: 10.14744/eej.2022.39200.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional needle irrigation, Passive Ultrasonic Irrigation with 3*20 sn and Passive Ultrasonic Irrigation with 6*10 sn in people with Postoperative Pain, run by Esin Özlek.
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 6 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: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hüseyin Gündüz (+905413523162, gunduzdt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score Scala (time frame: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711029, which also lists 4 linked publications.
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 2 Dec 2024.