Pulpal InflammationNCT07108842
Assessment of Pain Using Two Different Irrigation Systems After Root Canal Treatment
A study testing Conventional Needle Irrigation, endoactivator and Irrigation Solution in people with Pulpal Inflammation, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
assessment of pain using two different irrigation systems after root canal treatment Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulpal Inflammation
- What is being tested?
- Conventional Needle Irrigation, endoactivator and Irrigation Solution
- 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
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2024to 2 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single rooted teeth (Anterior or posterior)
- Teeth with symptomatic irreversible pulpitis with acute apical periodontitis
- Age group 18-65 years
Who cannot join
- Non-restorable teeth, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
- Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
- Patients that had any serious medical illness or with systemic disorders
- Previous root canal treatment
- Periodontally compromised teeth
- Presence of sinus tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain After Using Two Different Irrigation Systems During Endodontic Treatment
assessment of pain using two different irrigation systems after root canal treatment
- Conditions
- Pulpal Inflammation
- Being tested
- Conventional Needle Irrigation, Conventional Needle Irrigation (Control Group), endoactivator, Irrigation Solution, Sonic Irrigation with EndoActivator (Experimental Group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Needle IrrigationProcedure or surgery
Also called Sonic Irrigation with EndoActivator (Experimental Group)
Patients in this arm will receive traditional syringe and needle irrigation using a 30-gauge side-vented needle. 2.5% sodium hypochlorite will be used as the irrigant, delivered 1-2 mm short of working length intermittently during root canal instrumentation. No activation device will be used.
Conventional Needle Irrigation (Control Group)Device
Also called use of endoactivator
Patients in this arm will receive traditional syringe and needle irrigation using a 30-gauge side-vented needle. 2.5% sodium hypochlorite will be used as the irrigant, delivered 1-2 mm short of working length intermittently during root canal instrumentation. No activation device will be used.
endoactivatorDevice
in group 2 irrigation done with endoactivator
Irrigation SolutionDevice
irrigation protocol done with disposable syringe
Irrigation SolutionDevice
irrigation protocol done with endoactivator
Sonic Irrigation with EndoActivator (Experimental Group)Device
Patients in this arm will receive sonic activation of the irrigant using the EndoActivator device during root canal treatment. After initial instrumentation and irrigation with 2.5% sodium hypochlorite, the irrigant will be activated using a medium-sized (25/04) EndoActivator tip for 30 seconds per canal at a sonic frequency (~6000 cycles/min), to enhance cleaning and irrigant penetration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Needle Irrigation (Control Group) | Active comparator | Patients in this group will receive traditional syringe and needle irrigation during root canal treatment. An open ended irrigation needle will be used to deliver 2.5% sodium hypochlorite into the root canal system. The needle will be placed 1-2 mm short of the working length, and irrigation will be performed intermittently during canal instrumentation. No additional activation method will be used. Receives: Procedure: Conventional Needle Irrigation; Device: Conventional Needle Irrigation (Control Group); Device: Irrigation Solution |
| Sonic Irrigation using EndoActivator (Intervention Group) | Experimental | Patients in this group will receive sonic activation of the irrigant using the EndoActivator device during root canal treatment. After instrumentation and irrigation with 2.5% sodium hypochlorite, the irrigant will be activated using the EndoActivator with a medium-sized (25/04) polymer tip. The device will operate at sonic frequencies (~6000 cycles/min) for 30 seconds per canal to enhance irrigant penetration and cleaning efficacy, particularly in the apical third and lateral canals. Receives: Device: endoactivator; Device: Irrigation Solution; Device: Sonic Irrigation with EndoActivator (Experimental Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Assessment of postoperative pain intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Pain scores will be recorded at 6 hours, 24 hours, and 48 hours after completion of root canal treatment.
Secondary outcomes (1)
Analgesic Consumption
Number of analgesic tablets (e.g., ibuprofen/paracetamol) consumed by patients within the first 48 hours post-treatment.
Measured: 0 to 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start3 Jun 2024
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulpal InflammationStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Farhana Altaf, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108842
- Sponsor's protocol ID
- Dr Farhana
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
PubMed 20647083
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Using Two Different Irrigation Systems During Endodontic Treatment
- ClinicalTrials.gov ID
- NCT07108842
- Acronym / sponsor ID
- Dr Farhana
- Conditions
- Pulpal Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 7 Aug 2025 (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.
assessment of pain using two different irrigation systems after root canal treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Needle Irrigation (Control Group) | Active comparator | Procedure: Conventional Needle Irrigation, Device: Conventional Needle Irrigation (Control Group), Device: Irrigation SolutionPatients in this group will receive traditional syringe and needle irrigation during root canal treatment. An open ended irrigation needle will be used to deliver 2.5% sodium hypochlorite into the root canal system. The needle will be placed 1-2 mm short of the working length, and irrigation will be performed intermittently during canal instrumentation. No additional activation method will be used. |
| Sonic Irrigation using EndoActivator (Intervention Group) | Experimental | Device: endoactivator, Device: Irrigation Solution, Device: Sonic Irrigation with EndoActivator (Experimental Group)Patients in this group will receive sonic activation of the irrigant using the EndoActivator device during root canal treatment. After instrumentation and irrigation with 2.5% sodium hypochlorite, the irrigant will be activated using the EndoActivator with a medium-sized (25/04) polymer tip. The device will operate at sonic frequencies (~6000 cycles/min) for 30 seconds per canal to enhance irrigant penetration and cleaning efficacy, particularly in the apical third and lateral canals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single rooted teeth (Anterior or posterior)
- Teeth with symptomatic irreversible pulpitis with acute apical periodontitis
- Age group 18-65 years
Key exclusion criteria (6 listed)
- Non-restorable teeth, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
- Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
- Patients that had any serious medical illness or with systemic disorders
- Previous root canal treatment
- Periodontally compromised teeth
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 IrrigationAlso: Sonic Irrigation with EndoActivator (Experimental Group)Patients in this arm will receive traditional syringe and needle irrigation using a 30-gauge side-vented needle. 2.5% sodium hypochlorite will be used as the irrigant, delivered 1-2 mm short of working length intermittently during root canal instrumentation. No activation device will be used. | Procedure or surgery | Conventional Needle Irrigation (Control Group) |
| Conventional Needle Irrigation (Control Group)Also: use of endoactivatorPatients in this arm will receive traditional syringe and needle irrigation using a 30-gauge side-vented needle. 2.5% sodium hypochlorite will be used as the irrigant, delivered 1-2 mm short of working length intermittently during root canal instrumentation. No activation device will be used. | Device | Conventional Needle Irrigation (Control Group) |
| endoactivatorin group 2 irrigation done with endoactivator | Device | Sonic Irrigation using EndoActivator (Intervention Group) |
| Irrigation Solutionirrigation protocol done with disposable syringe | Device | Conventional Needle Irrigation (Control Group), Sonic Irrigation using EndoActivator (Intervention Group) |
| Irrigation Solutionirrigation protocol done with endoactivator | Device | Conventional Needle Irrigation (Control Group), Sonic Irrigation using EndoActivator (Intervention Group) |
| Sonic Irrigation with EndoActivator (Experimental Group)Patients in this arm will receive sonic activation of the irrigant using the EndoActivator device during root canal treatment. After initial instrumentation and irrigation with 2.5% sodium hypochlorite, the irrigant will be activated using a medium-sized (25/04) EndoActivator tip for 30 seconds per canal at a sonic frequency (~6000 cycles/min), to enhance cleaning and irrigant penetration. | Device | Sonic Irrigation using EndoActivator (Intervention Group) |
Primary outcome
Postoperative Pain
Time frame: Pain scores will be recorded at 6 hours, 24 hours, and 48 hours after completion of root canal treatment.
Assessment of postoperative pain intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
1 secondary outcome
Analgesic Consumption
Time frame: 0 to 48 hours after treatment
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 7 Aug 2025.
- Background: PubMed 20647083Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
- 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 Conventional Needle Irrigation, endoactivator and Irrigation Solution in people with Pulpal Inflammation, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
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 3 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: finished, as of the sponsor's last update on 7 Aug 2025. 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 Pakistan. 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: Pain scores will be recorded at 6 hours, 24 hours, and 48 hours after completion of root canal treatment.). 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 NCT07108842, which also lists 1 linked publication.
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 7 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.