Asymptomatic Apical PeriodontitisVASNCT07847333
Sonic Irrigation Activation for Postoperative Pain After Root Canal Treatment
A study testing Sonic Irrigation Activation Using EndoActivator and Conventional Syringe Irrigation in people with Asymptomatic Apical Periodontitis, run by Saidu College of Dentistry.
Trial summary
This randomized controlled clinical trial will evaluate whether sonic activation of the root canal irrigant using the EndoActivator system reduces postoperative pain after root canal treatment compared with conventional syringe irrigation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis
- What is being tested?
- Sonic Irrigation Activation Using EndoActivator and Conventional Syringe Irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2026to 30 Nov 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Either sex.
- Restorable permanent single-rooted premolar requiring primary root canal treatment.
- Clinical diagnosis of pulp necrosis.
- Radiographic evidence of apical periodontitis or periapical radiolucency.
- Absence of spontaneous preoperative pain.
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- No clinically significant pain on percussion or palpation.
- No swelling, sinus tract, or purulent drainage.
- Adequate periodontal support.
- No previous endodontic treatment.
- Ability to understand and use the pain-rating scale.
- Willingness to comply with postoperative follow-up.
- Provision of written informed consent.
Who cannot join
- Symptomatic apical periodontitis or acute apical abscess.
- Preoperative spontaneous pain.
- Swelling or sinus tract.
- Previously treated teeth.
- Root fracture.
- Severe root curvature.
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- Open apices.
- Root resorption.
- Severely calcified or obliterated canals.
- Severe periodontal disease.
- Systemic disease likely to substantially influence pain perception or healing.
- Use of analgesic or anti-inflammatory medication within 48 hours before treatment.
- Recent antibiotic therapy.
- Inability to complete postoperative follow-up.
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 Sonic Irrigation Activation on Postoperative Pain After Root Canal Treatment in Adults With Asymptomatic Apical Periodontitis: A Randomized Controlled Trial
This randomized controlled clinical trial will evaluate whether sonic activation of the root canal irrigant using the EndoActivator system reduces postoperative pain after root canal treatment compared with conventional syringe irrigation.
Adults aged 18 to 60 years with pulp necrosis and asymptomatic apical periodontitis involving restorable permanent single-rooted premolars will be eligible to participate. A total of 176 participants will be randomly assigned in a 1:1 ratio to either conventional syringe irrigation or sonic irrigation activation using the EndoActivator system.
Read more
Root canal treatment procedures, including instrumentation, irrigant concentration and volume, irrigation delivery, obturation, and postoperative instructions, will be standardized between the two groups. The main difference between the groups will be the method used to activate the irrigant.
The primary outcome will be postoperative pain intensity measured using a 100-mm Visual Analog Scale (VAS) 24 hours after root canal treatment. Pain will also be assessed at 6, 48, and 72 hours and at 7 and 14 days. Additional outcomes will include the proportion of participants reporting pain, rescue analgesic use, time to first analgesic use, total analgesic consumption, and adverse events.
The study will be conducted in the Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Saidu Sharif, Swat, Khyber Pakhtunkhwa, Pakistan. Each participant will be followed for 14 days after treatment.
Read the detailed description
This is a prospective, two-arm, parallel-group randomized controlled clinical trial designed to compare the effect of sonic irrigation activation with conventional syringe irrigation on postoperative pain following root canal treatment in adults with pulp necrosis and asymptomatic apical periodontitis.
Eligible participants will be adults aged 18-60 years requiring primary root canal treatment of restorable permanent single-rooted premolars. Participants must have a clinical diagnosis of pulp necrosis and radiographic evidence of apical periodontitis/periapical radiolucency without spontaneous preoperative pain or clinically significant pain on percussion or palpation. Participants with symptomatic apical periodontitis, acute apical abscess, previous endodontic treatment, root fracture, severe root curvature, open apices, root resorption, severely calcified or obliterated canals, severe periodontal disease, or other specified exclusion criteria will not be enrolled.
A total of 176 participants will be recruited and allocated in a 1:1 ratio using a computer-generated randomization sequence with variable block randomization. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. The operator cannot be blinded because the irrigation activation method must be known during treatment. However, the postoperative outcome assessor will remain blinded to treatment allocation, and the statistician will analyze coded treatment groups.
In the conventional irrigation group, final irrigation will be performed using a sterile side-vented endodontic irrigation needle positioned approximately 1-2 mm short of the working length. In the sonic activation group, the same irrigants, concentrations, volumes, sequence, and exposure times will be used, followed by activation using the EndoActivator system. The EndoActivator tip will be positioned approximately 1-2 mm short of the established working length without binding. The activation protocol will be standardized before recruitment.
The primary outcome will be postoperative pain intensity measured on a 100-mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the worst imaginable pain, assessed at 24 hours after treatment. Secondary outcomes will include pain intensity at 6, 48, and 72 hours and 7 and 14 days; the proportion of participants reporting postoperative pain; requirement for rescue analgesics; time to first analgesic use; total number of analgesic tablets consumed during the 14-day follow-up; and adverse events or procedural complications.
Postoperative pain will be assessed longitudinally over the 14-day follow-up period. A linear mixed-effects model will be used to analyze repeated pain measurements, with treatment group, time, and treatment-by-time interaction as fixed effects and participant as a random effect. The difference between groups at the primary 24-hour endpoint will be reported with a 95% confidence interval and p-value.
The study will be conducted at the Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Saidu Sharif, Swat, Khyber Pakhtunkhwa, Pakistan. Ethical approval and prospective trial registration will be obtained before recruitment.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- Sonic Irrigation Activation Using EndoActivator, Conventional Syringe Irrigation
- Keywords
- Postoperative pain, Conventional syringe irrigation, Asymptomatic Apical Periodontitis, 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.
Sonic Irrigation Activation Using EndoActivatorProcedure or surgery
Sonic activation of root canal irrigant will be performed using the EndoActivator system after delivery of the standardized final irrigation solution. The same irrigants, concentrations, volumes, sequence, and exposure times will be used in both treatment groups. A flexible polymer EndoActivator tip of appropriate size will be positioned approximately 1-2 mm short of the established working length without binding. The device will be operated using a prespecified activation protocol, with controlled movement within the irrigant-filled canal. Tip size, device setting, activation duration, number of activation cycles, and insertion depth will be recorded for each participant.
Conventional Syringe IrrigationProcedure or surgery
Conventional irrigation will be performed using a sterile side-vented endodontic irrigation needle positioned approximately 1-2 mm short of the established working length without binding. Irrigation will be performed using gentle, standardized short vertical movements. The same irrigants, concentrations, volumes, sequence, and exposure times will be used as in the sonic activation group. No mechanical activation device will be used.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Syringe Irrigation | Active comparator | Participants will receive standardized root canal treatment with conventional syringe irrigation using a sterile side-vented endodontic irrigation needle. The needle will be positioned approximately 1-2 mm short of the established working length without binding. Irrigation will be performed using gentle, standardized short vertical movements. The same irrigants, concentrations, volumes, sequence, exposure times, and other treatment procedures will be used as in the sonic activation group. No mechanical activation device will be used. Receives: Procedure: Conventional Syringe Irrigation |
| Sonic Irrigation Activation Using EndoActivator | Experimental | Participants will receive standardized root canal treatment with sonic irrigation activation using the EndoActivator system. The same irrigants, concentrations, volumes, sequence, and exposure times used in the conventional irrigation group will be applied. A flexible polymer EndoActivator tip of appropriate size will be positioned approximately 1-2 mm short of the established working length without binding. Sonic activation will be performed using a prespecified activation protocol, with the tip moved in a controlled manner within the irrigant-filled canal. Tip size, device setting, activation duration, number of cycles, and insertion depth will be recorded. Receives: Procedure: Sonic Irrigation Activation Using EndoActivator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 mm representing no pain and 100 mm representing the worst imaginable pain. Higher VAS scores indicate greater postoperative pain.
Measured: 24 hours after root canal treatment
Secondary outcomes (1)
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS) at Follow-Up
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 mm representing no pain and 100 mm representing the worst imaginable pain. Higher VAS scores indicate greater postoperative pain.
Measured: 6 hours, 48 hours, 72 hours, 7 days, and 14 days after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion17 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Apical PeriodontitisStudies 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
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: conventional syringe irrigation or sonic irrigation activation using the EndoActivator system. Participants will receive root canal treatment according to a standardized clinical protocol, with the irrigation activation method being the planned difference between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saidu College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847333
- Sponsor's protocol ID
- SCD-OPER-2026-20
- Acronym
- VAS
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 29 Sep 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 with other researchers. The study does not currently have a plan for external sharing of individual participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sonic Irrigation Activation on Postoperative Pain After Root Canal Treatment in Adults With Asymptomatic Apical Periodontitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07847333
- Acronym / sponsor ID
- VAS / SCD-OPER-2026-20
- Conditions
- Asymptomatic Apical Periodontitis
- Keywords
- Postoperative pain, Conventional syringe irrigation, Asymptomatic Apical Periodontitis, EndoActivator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Saidu College of DentistryUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 17 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Sep 2026 (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.
This randomized controlled clinical trial will evaluate whether sonic activation of the root canal irrigant using the EndoActivator system reduces postoperative pain after root canal treatment compared with conventional syringe irrigation.
Adults aged 18 to 60 years with pulp necrosis and asymptomatic apical periodontitis involving restorable permanent single-rooted premolars will be eligible to participate. A total of 176 participants will be randomly assigned in a 1:1 ratio to either conventional syringe irrigation or sonic irrigation activation using the EndoActivator system.
Root canal treatment procedures, including instrumentation, irrigant concentration and volume, irrigation delivery, obturation, and postoperative instructions, will be standardized between the two groups. The main difference between the groups will be the method used to activate the irrigant.
The primary outcome will be postoperative pain intensity measured using a 100-mm Visual Analog Scale (VAS) 24 hours after root canal treatment. Pain will also be assessed at 6, 48, and 72 hours and at 7 and 14 days. Additional outcomes will include the proportion of participants reporting pain, rescue analgesic use, time to first analgesic use, total analgesic consumption, and adverse events.
The study will be conducted in the Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Saidu Sharif, Swat, Khyber Pakhtunkhwa, Pakistan. Each participant will be followed for 14 days after treatment.
Detailed description
This is a prospective, two-arm, parallel-group randomized controlled clinical trial designed to compare the effect of sonic irrigation activation with conventional syringe irrigation on postoperative pain following root canal treatment in adults with pulp necrosis and asymptomatic apical periodontitis.
Eligible participants will be adults aged 18-60 years requiring primary root canal treatment of restorable permanent single-rooted premolars. Participants must have a clinical diagnosis of pulp necrosis and radiographic evidence of apical periodontitis/periapical radiolucency without spontaneous preoperative pain or clinically significant pain on percussion or palpation. Participants with symptomatic apical periodontitis, acute apical abscess, previous endodontic treatment, root fracture, severe root curvature, open apices, root resorption, severely calcified or obliterated canals, severe periodontal disease, or other specified exclusion criteria will not be enrolled.
A total of 176 participants will be recruited and allocated in a 1:1 ratio using a computer-generated randomization sequence with variable block randomization. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. The operator cannot be blinded because the irrigation activation method must be known during treatment. However, the postoperative outcome assessor will remain blinded to treatment allocation, and the statistician will analyze coded treatment groups.
In the conventional irrigation group, final irrigation will be performed using a sterile side-vented endodontic irrigation needle positioned approximately 1-2 mm short of the working length. In the sonic activation group, the same irrigants, concentrations, volumes, sequence, and exposure times will be used, followed by activation using the EndoActivator system. The EndoActivator tip will be positioned approximately 1-2 mm short of the established working length without binding. The activation protocol will be standardized before recruitment.
The primary outcome will be postoperative pain intensity measured on a 100-mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the worst imaginable pain, assessed at 24 hours after treatment. Secondary outcomes will include pain intensity at 6, 48, and 72 hours and 7 and 14 days; the proportion of participants reporting postoperative pain; requirement for rescue analgesics; time to first analgesic use; total number of analgesic tablets consumed during the 14-day follow-up; and adverse events or procedural complications.
Postoperative pain will be assessed longitudinally over the 14-day follow-up period. A linear mixed-effects model will be used to analyze repeated pain measurements, with treatment group, time, and treatment-by-time interaction as fixed effects and participant as a random effect. The difference between groups at the primary 24-hour endpoint will be reported with a 95% confidence interval and p-value.
The study will be conducted at the Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Saidu Sharif, Swat, Khyber Pakhtunkhwa, Pakistan. Ethical approval and prospective trial registration will be obtained before recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: conventional syringe irrigation or sonic irrigation activation using the EndoActivator system. Participants will receive root canal treatment according to a standardized clinical protocol, with the irrigation activation method being the planned difference between groups.
| Arm | Type | Receives |
|---|---|---|
| Conventional Syringe Irrigation | Active comparator | Procedure: Conventional Syringe IrrigationParticipants will receive standardized root canal treatment with conventional syringe irrigation using a sterile side-vented endodontic irrigation needle. The needle will be positioned approximately 1-2 mm short of the established working length without binding. Irrigation will be performed using gentle, standardized short vertical movements. The same irrigants, concentrations, volumes, sequence, exposure times, and other treatment procedures will be used as in the sonic activation group. No mechanical activation device will be used. |
| Sonic Irrigation Activation Using EndoActivator | Experimental | Procedure: Sonic Irrigation Activation Using EndoActivatorParticipants will receive standardized root canal treatment with sonic irrigation activation using the EndoActivator system. The same irrigants, concentrations, volumes, sequence, and exposure times used in the conventional irrigation group will be applied. A flexible polymer EndoActivator tip of appropriate size will be positioned approximately 1-2 mm short of the established working length without binding. Sonic activation will be performed using a prespecified activation protocol, with the tip moved in a controlled manner within the irrigant-filled canal. Tip size, device setting, activation duration, number of cycles, and insertion depth will be recorded. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adults aged 18-60 years.
- Either sex.
- Restorable permanent single-rooted premolar requiring primary root canal treatment.
- Clinical diagnosis of pulp necrosis.
- Radiographic evidence of apical periodontitis or periapical radiolucency.
Key exclusion criteria (14 listed)
- Symptomatic apical periodontitis or acute apical abscess.
- Preoperative spontaneous pain.
- Swelling or sinus tract.
- Previously treated teeth.
- Root fracture.
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 |
|---|---|---|
| Sonic Irrigation Activation Using EndoActivatorSonic activation of root canal irrigant will be performed using the EndoActivator system after delivery of the standardized final irrigation solution. The same irrigants, concentrations, volumes, sequence, and exposure times will be used in both treatment groups. A flexible polymer EndoActivator tip of appropriate size will be positioned approximately 1-2 mm short of the established working length without binding. The device will be operated using a prespecified activation protocol, with controlled movement within the irrigant-filled canal. Tip size, device setting, activation duration, number of activation cycles, and insertion depth will be recorded for each participant. | Procedure or surgery | Sonic Irrigation Activation Using EndoActivator |
| Conventional Syringe IrrigationConventional irrigation will be performed using a sterile side-vented endodontic irrigation needle positioned approximately 1-2 mm short of the established working length without binding. Irrigation will be performed using gentle, standardized short vertical movements. The same irrigants, concentrations, volumes, sequence, and exposure times will be used as in the sonic activation group. No mechanical activation device will be used. | Procedure or surgery | Conventional Syringe Irrigation |
Primary outcome
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS)
Time frame: 24 hours after root canal treatment
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 mm representing no pain and 100 mm representing the worst imaginable pain. Higher VAS scores indicate greater postoperative pain.
1 secondary outcome
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS) at Follow-Up
Time frame: 6 hours, 48 hours, 72 hours, 7 days, and 14 days after root canal treatment
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 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The study does not currently have a plan for external sharing of individual participant-level data.
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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 Sonic Irrigation Activation Using EndoActivator and Conventional Syringe Irrigation in people with Asymptomatic Apical Periodontitis, run by Saidu College of Dentistry.
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 13 inclusion and 14 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 29 Sep 2026. 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 Dr Abdullah Dr Abdullah, BDS,FCPS (+92 333 9256750 ext. +92 333 925675, drabdullahscd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS) (time frame: 24 hours after root canal treatment). 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 29 Sep 2026.