Post Operative PainNCT07062419
Effect of Sonic Activation of Irrigant on Post Operative Pain After Root Canal Treatment
A study testing endoactivator in people with Post Operative Pain and Root Canal Therapy, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial summary
Fifty-eight patients aged 18-60 years, diagnosed with symptomatic or asymptomatic apical periodontitis will be randomly allocated into two groups: Group A (EndoActivator) and Group B (conventional syringe irrigation). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Root Canal Therapy
- What is being tested?
- endoactivator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- irreversible pulpitis
- symptomatic apical periodontitis
- asymptomatic apical periodontitis
- compliant patients
- sufficient ferrule for post operative restoration
Who cannot join
- periapical abcess
- severe periodontal disease with guarded periodontal prognosis
- teeth with guarded post operative restoration prognosis
- non compliant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sonic Activation of Irrigant on Post Operative Pain After Root Canal Treatment on Permanent Dentition: A Randomized Clinical Study
Fifty-eight patients aged 18-60 years, diagnosed with symptomatic or asymptomatic apical periodontitis will be randomly allocated into two groups: Group A (EndoActivator) and Group B (conventional syringe irrigation). preoperative pain will be evaluated in all patients requiring root canal treatment using visual analogue scale before initiating the procedure.
Postoperative pain will be measured using the Visual Analog Scale (VAS) at 24, 36, 48 hours and one week.
Read the detailed description
This randomized clinical study will evaluate the effect of two different irrigation techniques on postoperative pain following root canal treatment in patients with apical periodontitis. A total of 58 patients will be randomly assigned to one of two groups: one group will receive irrigation using the EndoActivator system, while the other group undergo conventional syringe irrigation. The objective is to determine whether the irrigation technique influences the level of postoperative discomfort experienced by patients. Pain levels will be assessed at specific time intervals to track the pattern of recovery and provide insight into the clinical effectiveness of each method in terms of patient comfort.
- Conditions
- Post Operative Pain, Root Canal Therapy
- Being tested
- 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.
endoactivatorDevice
activation of irrigant during root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| one group will receive irrigation during root canal treatment will be activated by an Endoactivator | Experimental | activation of an irrigant by using certain ultrasonic frequency to enhance antimicrobial action of irrigant Receives: Device: endoactivator |
| One group will receive irrigation during root canal treatment in which activation will not occur | No intervention | This group consists of patients who will receive irrigation during root canal treatment using the conventional syringe irrigation technique without the use of the EndoActivator system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain using endoactivator
post operative pain will be marked on visual analogue scale (VAS). the lower the score the less pain will be and vice versa.
maximum score 10 minimum score 0 0 to 10 depicting no pain to worst pain
Measured: before procedure, after 24 hours, 36 hours , 48 hours, 1 week
post operative pain
pain will be evaluatedon visual analogue scale (VAS). the lower the score the less pain will be and vice versa.
maximum score 10 minimum score 0 0 to 10 depicting no pain to worst pain
Measured: before procedure, after 24 hours , 36 hours , 48 hours , 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jan 2025
- Primary completion25 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Rasool, CMH Lahore Medical College and Institute of Dentistry
- Investigators
- Imran Khan, BDS FCPS, Study director, 28 military dental centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062419
- Sponsor's protocol ID
- 107/Civ/Trg/Op/15/24
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sonic Activation of Irrigant on Post Operative Pain After Root Canal Treatment on Permanent Dentition: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07062419
- Acronym / sponsor ID
- 107/Civ/Trg/Op/15/24
- Conditions
- Post Operative Pain, Root Canal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 14 Jul 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.
Fifty-eight patients aged 18-60 years, diagnosed with symptomatic or asymptomatic apical periodontitis will be randomly allocated into two groups: Group A (EndoActivator) and Group B (conventional syringe irrigation). preoperative pain will be evaluated in all patients requiring root canal treatment using visual analogue scale before initiating the procedure.
Postoperative pain will be measured using the Visual Analog Scale (VAS) at 24, 36, 48 hours and one week.
Detailed description
This randomized clinical study will evaluate the effect of two different irrigation techniques on postoperative pain following root canal treatment in patients with apical periodontitis. A total of 58 patients will be randomly assigned to one of two groups: one group will receive irrigation using the EndoActivator system, while the other group undergo conventional syringe irrigation. The objective is to determine whether the irrigation technique influences the level of postoperative discomfort experienced by patients. Pain levels will be assessed at specific time intervals to track the pattern of recovery and provide insight into the clinical effectiveness of each method in terms of patient comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one group will receive irrigation during root canal treatment will be activated by an Endoactivator | Experimental | Device: endoactivatoractivation of an irrigant by using certain ultrasonic frequency to enhance antimicrobial action of irrigant |
| One group will receive irrigation during root canal treatment in which activation will not occur | No intervention | –This group consists of patients who will receive irrigation during root canal treatment using the conventional syringe irrigation technique without the use of the EndoActivator system. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- irreversible pulpitis
- symptomatic apical periodontitis
- asymptomatic apical periodontitis
- compliant patients
- sufficient ferrule for post operative restoration
Key exclusion criteria (4 listed)
- periapical abcess
- severe periodontal disease with guarded periodontal prognosis
- teeth with guarded post operative restoration prognosis
- non compliant patients
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 |
|---|---|---|
| endoactivatoractivation of irrigant during root canal treatment | Device | one group will receive irrigation during root canal treatment will be activated by an Endoactivator |
Primary outcome
post operative pain using endoactivator
Time frame: before procedure, after 24 hours, 36 hours , 48 hours, 1 week
post operative pain will be marked on visual analogue scale (VAS). the lower the score the less pain will be and vice versa. maximum score 10 minimum score 0 0 to 10 depicting no pain to worst pain
post operative pain
Time frame: before procedure, after 24 hours , 36 hours , 48 hours , 1 week
pain will be evaluatedon visual analogue scale (VAS). the lower the score the less pain will be and vice versa. maximum score 10 minimum score 0 0 to 10 depicting no pain to worst pain
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 1 Oct 2025.
- 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.
Imran Khan, BDS FCPS study director
28 military dental centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoactivator in people with Post Operative Pain and Root Canal Therapy, run by CMH Lahore Medical College and Institute of Dentistry 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 5 inclusion and 4 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 1 Oct 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?
post operative pain using endoactivator (time frame: before procedure, after 24 hours, 36 hours , 48 hours, 1 week). The study lists 2 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 1 Oct 2025.