Postoperative PainNCT06358833
Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems
A study testing endodontic needle (EN) and Endodontic activation (EA) in people with Postoperative Pain and Irreversible Pulpitis, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
Summary: After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pain, Irreversible Pulpitis
- What is being tested?
- endodontic needle (EN) and Endodontic activation (EA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Apr 2024to 30 Apr 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years of age) visiting the College of Dentistry and undergoing root canal treatment in posterior teeth (molars and premolars).
- Teeth having fully formed roots with mature apices.
- Patients willing to collaborate in the study must sign a written consent form.
- Diagnosis of irreversible pulpitis in posterior tooth/teeth requiring root canal treatment.
- No history of allergy to the anesthesia solution.
- Classified as class I, II in the American Society of Anesthesiologists Physical Status Classification System.
Who cannot join
- Patients diagnosed with pulp necrosis in the tooth require root canal treatment.
- Mentally or medically compromised patients.
- Pregnant women.
- Patients on any medications for the past two weeks
- Patients who refuse to participate in the study.
- Patients with a history of allergy from any of the contents of local anesthesia or rubber dam material.
- Non-restorable teeth
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Muhammad Zubair Ahmad
Ar Rass, Al-Qassim Region, 58883
About this study
Official title: Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation: A Randomized Controlled Pragmatic Clinical Trial
Summary:
After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain.
Read the detailed description
Background:
One of the primary objectives following root canal therapy is to alleviate pain. While postoperative pain is undesirable, it is often considered a common sensation following endodontic treatment.
Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task, even when using precise rotary, hand, or hybrid instruments. Therefore, irrigation plays a crucial role in the cleaning and shaping process.
Traditional root canal irrigation typically involves the use of an endodontic needle (EN) to disinfect the root canal. However, a newer approach called endodontic activation (EA) has been suggested to enhance root canal disinfection by activating irrigants within the canal.
Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment.
Rationale:
No study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) on postoperative pain using a pragmatic approach. Therefore, the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation.
Study objectives:
The study aims to assess and compare the levels of postoperative pain following endodontic activation (EA) of irrigants using the Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) versus conventional endodontic needle (EN) irrigation in root canal therapy.
Methods In this prospective single-blind, parallel-armed, randomized clinical trial, standard root canal preparation will be done; patients will be randomly assigned into one of the two groups. In the final irrigation protocol, group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique.
- Conditions
- Postoperative Pain, Irreversible Pulpitis
- Being tested
- endodontic needle (EN), Endodontic activation (EA)
- Keywords
- root canal treatment, irrigation, ultrasonic activation, Endo1 Ultrasonic Endo Activate Device
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endodontic needle (EN)Procedure or surgery
the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.
Endodontic activation (EA)Procedure or surgery
the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.
| Study group | Role | What they receive |
|---|---|---|
| Endodontic needle (EN) | Active comparator | In this group, the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed. Receives: Procedure: endodontic needle (EN) |
| Endodontic activation (EA) | Experimental | In this group, the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed. Receives: Procedure: Endodontic activation (EA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Measured: 6 hours postoperatively
Postoperative pain
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Measured: 24 hours postoperatively
Postoperative pain
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Measured: 48 hours postoperatively
Postoperative pain
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Measured: 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Apr 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Zubair Ahmad, Qassim University
- Investigators
- Muhammad Zubair Ahmad, FCPS, Principal investigator, Qassim University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358833
- Sponsor's protocol ID
- 24-82-03
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; any future data-sharing request would require separate approval from the Committee of Research Ethics, Qassim University.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation: A Randomized Controlled Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT06358833
- Acronym / sponsor ID
- 24-82-03
- Conditions
- Postoperative Pain, Irreversible Pulpitis
- Keywords
- root canal treatment, irrigation, ultrasonic activation, Endo1 Ultrasonic Endo Activate Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Apr 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.
Summary:
After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain.
Detailed description
Background:
One of the primary objectives following root canal therapy is to alleviate pain. While postoperative pain is undesirable, it is often considered a common sensation following endodontic treatment.
Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task, even when using precise rotary, hand, or hybrid instruments. Therefore, irrigation plays a crucial role in the cleaning and shaping process.
Traditional root canal irrigation typically involves the use of an endodontic needle (EN) to disinfect the root canal. However, a newer approach called endodontic activation (EA) has been suggested to enhance root canal disinfection by activating irrigants within the canal.
Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment.
Rationale:
No study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) on postoperative pain using a pragmatic approach. Therefore, the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation.
Study objectives:
The study aims to assess and compare the levels of postoperative pain following endodontic activation (EA) of irrigants using the Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) versus conventional endodontic needle (EN) irrigation in root canal therapy.
Methods In this prospective single-blind, parallel-armed, randomized clinical trial, standard root canal preparation will be done; patients will be randomly assigned into one of the two groups. In the final irrigation protocol, group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endodontic needle (EN) | Active comparator | Procedure: endodontic needle (EN)In this group, the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed. |
| Endodontic activation (EA) | Experimental | Procedure: Endodontic activation (EA)In this group, the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (>18 years of age) visiting the College of Dentistry and undergoing root canal treatment in posterior teeth (molars and premolars).
- Teeth having fully formed roots with mature apices.
- Patients willing to collaborate in the study must sign a written consent form.
- Diagnosis of irreversible pulpitis in posterior tooth/teeth requiring root canal treatment.
- No history of allergy to the anesthesia solution.
Key exclusion criteria (7 listed)
- Patients diagnosed with pulp necrosis in the tooth require root canal treatment.
- Mentally or medically compromised patients.
- Pregnant women.
- Patients on any medications for the past two weeks
- Patients who refuse to participate in the study.
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 |
|---|---|---|
| endodontic needle (EN)the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed. | Procedure or surgery | Endodontic needle (EN) |
| Endodontic activation (EA)the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed. | Procedure or surgery | Endodontic activation (EA) |
Primary outcome
Postoperative pain
Time frame: 6 hours postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Postoperative pain
Time frame: 24 hours postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Postoperative pain
Time frame: 48 hours postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
Postoperative pain
Time frame: 1 week postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
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 12 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; any future data-sharing request would require separate approval from the Committee of Research Ethics, Qassim University.
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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.
Muhammad Zubair Ahmad, FCPS principal investigator
Qassim University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endodontic needle (EN) and Endodontic activation (EA) in people with Postoperative Pain and Irreversible Pulpitis, run by Qassim University at 1 site in Saudi Arabia.
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 6 inclusion and 7 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 12 Jun 2026. 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 Saudi Arabia. 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: 6 hours postoperatively). The study lists 4 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 12 Jun 2026; AzTrials last refreshed its copy on 4 Nov 2026.