Irriversible PulpitisNCT07196215
Comparison of Post-operative Pain After Different Root Canal Irrigant Activation Methods
A study testing passive ultrasonic activation and sonic activation in people with Irriversible Pulpitis and Irrigation, run by RANA AHMAD.
Trial summary
root canal irrigation protocol Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irriversible Pulpitis, Irrigation, Activation, Patient
- What is being tested?
- passive ultrasonic activation and sonic activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2027
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients in good health with no systemic disease (ASA Class I or II)
- Age range is between 20 to 50 years.
- Patients diagnosed with symptomatic irreversible pulpitis in maxillary incisor teeth.
- Patients who can understand VAS.
- Patients who give verbal consent to participate voluntarily in the study.
Who cannot join
- • History of systemic disorder.
- Pregnant / lactating females (As per medical record/verbally)
- Patients who had taken preoperative drugs as anti-inflammatory analgesic or antibiotics.
- Patients with swelling or acute peri-apical abscess.
- Tooth not suitable for restoration.
- Periodontally compromised teeth.
- Retreatment cases.
About this study
Official title: Comparison of Post-operative Pain After Different Root Canal Irrigant Activation Methods in Maxillary Incisors With Symptomatic Irreversible Pulpitis
root canal irrigation protocol
Read the detailed description
To compare mean post-operative pain intensity at different time intervals (24h and 48h) using visual analogue scale (VAS) in maxillary incisors with symptomatic irreversible pulpitis using two different irrigation activation methods (passive ultrasonic activation and sonic activation using EndoActivator).
- Conditions
- Irriversible Pulpitis, Irrigation, Activation, Patient
- Being tested
- passive ultrasonic activation, sonic activation
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive ultrasonic activationProcedure or surgery
passive ultrasonic irrigant activation will be performed by using a stainless steel ultrasonic Irrisafe file of size 20 (IRRI S 21/25; VDW, Germany) mounted on ultrasonic unit (Woodpecker Ultrasonic Scaler UDS-J). The file will be kept 2 mm short of working length loosely without binding to the canal. 2.5% NaOCl will be activated for 30 seconds by using a power setting of five
sonic activationProcedure or surgery
root canals will be filled with 2.5% sodium hypochlorite and medium size tip (red, 25/04) of EndoAcivator (YAHOPE A3, China) will be used keeping it 2 mm short of working length. The activation of irrigant will be done in 2-3 mm vertical strokes for 30 seconds in between each instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Passive ultrasonic activation | Active comparator | passive ultrasonic irrigant activation will be performed by using a stainless steel ultrasonic Irrisafe file of size 20 (IRRI S 21/25; VDW, Germany) mounted on ultrasonic unit (Woodpecker Ultrasonic Scaler UDS-J). The file will be kept 2 mm short of working length loosely without binding to the canal. 2.5% NaOCl will be activated for 30 seconds by using a power setting of five. Receives: Procedure: passive ultrasonic activation |
| Sonic activation | Active comparator | In group B, root canals will be filled with 2.5% sodium hypochlorite and medium size tip (red, 25/04) of EndoAcivator (YAHOPE A3, China) will be used keeping it 2 mm short of working length. The activation of irrigant will be done in 2-3 mm vertical strokes for 30 seconds in between each instrumentation Receives: Procedure: sonic activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score on visual analogue scale
After complete root canal irrigation and preparation, canals will be dried and a temporary dressing of Cavit will be placed. Patients will be reappointed for obturation. VAS scale ranging from 0-10 will be given to patient and will be demonstrated on how to record their pain and which will be recorded by the patient after 24 hours and 48 hours by marking on a chart ranging from 0-10 with 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain 7-10 = severe pain. On 5th day of follow-up, obturation will be done using single cone obturation method
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Irriversible PulpitisStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RANA AHMAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, RANA AHMAD, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196215
- Sponsor's protocol ID
- TUF/IRB/21/25
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: outcome measures
Publications
Gundogar M, Sezgin GP, Kaplan SS, Ozyurek H, Uslu G, Ozyurek T. Postoperative pain after different irrigation activation techniques: a randomized, clinical trial. Odontology. 2021 Apr;109(2):385-392. doi: 10.1007/s10266-020-00553-5. Epub 2020 Sep 11.
PubMed 32915346Narla RK, J RK, Pavuluri TC, P KC, Penumaka R, Nagelli RK. Effect of Different Irrigant Activation Techniques on the Penetration of Calcium Hydroxide, an Intracanal Medicament: An In Vitro Study. Cureus. 2023 Nov 13;15(11):e48768. doi: 10.7759/cureus.48768. eCollection 2023 Nov.
PubMed 380989137. Nivedhitha S. Influence of different irrigant activation techniques in post-operative endodontic pain-a review of literature. Int J Dentistry Oral Sci. 2021;8(5):2659-65.
6. Abou Khalaf Y, Hashem A, Kamel W, Badr M. Postoperative pain after different root canal irrigant activation methods; (randomized clinical trial). Future Dent J. 2021;7(1):1-6.
5. Elzainy P, Hussein W, Hashem A, Badr M. Post-operative pain after different root canal irrigant activation methods in patients with acute apical periodontitis (Randomized Clinical Trial). Open Access Maced J Med Sci. 2022;10(D):331-7.
Kumar P, Yadav SK, Chugh VK, Sharma R, Pathak K, Duraisamy A. Comparative Assessment of Postoperative Pain After Three Irrigation Techniques in Single-Rooted Teeth With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Controlled Trial. Cureus. 2024 Jul 29;16(7):e65618. doi: 10.7759/cureus.65618. eCollection 2024 Jul.
PubMed 392057533. Salim A, Darrag A, Ghoneim W. Post-operative pain after single-visit endodontic treatment using different root canal irrigation activating techniques. Egypt Dent J. 2021;67(4):3719-30.
Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
PubMed 17956561Parirokh M, Jalali S, Haghdoost AA, Abbott PV. Comparison of the effect of various irrigants on apically extruded debris after root canal preparation. J Endod. 2012 Feb;38(2):196-9. doi: 10.1016/j.joen.2011.10.027. Epub 2011 Dec 6.
PubMed 22244635
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Pain After Different Root Canal Irrigant Activation Methods in Maxillary Incisors With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07196215
- Acronym / sponsor ID
- TUF/IRB/21/25
- Conditions
- Irriversible Pulpitis, Irrigation, Activation, Patient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- RANA AHMADUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Sep 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.
root canal irrigation protocol
Detailed description
To compare mean post-operative pain intensity at different time intervals (24h and 48h) using visual analogue scale (VAS) in maxillary incisors with symptomatic irreversible pulpitis using two different irrigation activation methods (passive ultrasonic activation and sonic activation using EndoActivator).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive ultrasonic activation | Active comparator | Procedure: passive ultrasonic activationpassive ultrasonic irrigant activation will be performed by using a stainless steel ultrasonic Irrisafe file of size 20 (IRRI S 21/25; VDW, Germany) mounted on ultrasonic unit (Woodpecker Ultrasonic Scaler UDS-J). The file will be kept 2 mm short of working length loosely without binding to the canal. 2.5% NaOCl will be activated for 30 seconds by using a power setting of five. |
| Sonic activation | Active comparator | Procedure: sonic activationIn group B, root canals will be filled with 2.5% sodium hypochlorite and medium size tip (red, 25/04) of EndoAcivator (YAHOPE A3, China) will be used keeping it 2 mm short of working length. The activation of irrigant will be done in 2-3 mm vertical strokes for 30 seconds in between each instrumentation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients in good health with no systemic disease (ASA Class I or II)
Key exclusion criteria (7 listed)
- • History of systemic disorder.
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 |
|---|---|---|
| passive ultrasonic activationpassive ultrasonic irrigant activation will be performed by using a stainless steel ultrasonic Irrisafe file of size 20 (IRRI S 21/25; VDW, Germany) mounted on ultrasonic unit (Woodpecker Ultrasonic Scaler UDS-J). The file will be kept 2 mm short of working length loosely without binding to the canal. 2.5% NaOCl will be activated for 30 seconds by using a power setting of five | Procedure or surgery | Passive ultrasonic activation |
| sonic activationroot canals will be filled with 2.5% sodium hypochlorite and medium size tip (red, 25/04) of EndoAcivator (YAHOPE A3, China) will be used keeping it 2 mm short of working length. The activation of irrigant will be done in 2-3 mm vertical strokes for 30 seconds in between each instrumentation | Procedure or surgery | Sonic activation |
Primary outcome
pain score on visual analogue scale
Time frame: 48 hours
After complete root canal irrigation and preparation, canals will be dried and a temporary dressing of Cavit will be placed. Patients will be reappointed for obturation. VAS scale ranging from 0-10 will be given to patient and will be demonstrated on how to record their pain and which will be recorded by the patient after 24 hours and 48 hours by marking on a chart ranging from 0-10 with 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain 7-10 = severe pain. On 5th day of follow-up, obturation will be done using single cone obturation method
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 2025.
- Results publication: PubMed 32915346Gundogar M, Sezgin GP, Kaplan SS, Ozyurek H, Uslu G, Ozyurek T. Postoperative pain after different irrigation activation techniques: a randomized, clinical trial. Odontology. 2021 Apr;109(2):385-392. doi: 10.1007/s10266-020-00553-5. Epub 2020 Sep 11.
- Results publication: PubMed 38098913Narla RK, J RK, Pavuluri TC, P KC, Penumaka R, Nagelli RK. Effect of Different Irrigant Activation Techniques on the Penetration of Calcium Hydroxide, an Intracanal Medicament: An In Vitro Study. Cureus. 2023 Nov 13;15(11):e48768. doi: 10.7759/cureus.48768. eCollection 2023 Nov.
- Results publication7. Nivedhitha S. Influence of different irrigant activation techniques in post-operative endodontic pain-a review of literature. Int J Dentistry Oral Sci. 2021;8(5):2659-65.
- Results publication6. Abou Khalaf Y, Hashem A, Kamel W, Badr M. Postoperative pain after different root canal irrigant activation methods; (randomized clinical trial). Future Dent J. 2021;7(1):1-6.
- Results publication5. Elzainy P, Hussein W, Hashem A, Badr M. Post-operative pain after different root canal irrigant activation methods in patients with acute apical periodontitis (Randomized Clinical Trial). Open Access Maced J Med Sci. 2022;10(D):331-7.
- Results publication: PubMed 39205753Kumar P, Yadav SK, Chugh VK, Sharma R, Pathak K, Duraisamy A. Comparative Assessment of Postoperative Pain After Three Irrigation Techniques in Single-Rooted Teeth With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Controlled Trial. Cureus. 2024 Jul 29;16(7):e65618. doi: 10.7759/cureus.65618. eCollection 2024 Jul.
- Results publication3. Salim A, Darrag A, Ghoneim W. Post-operative pain after single-visit endodontic treatment using different root canal irrigation activating techniques. Egypt Dent J. 2021;67(4):3719-30.
- Results publication: PubMed 17956561Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
- Results publication: PubMed 22244635Parirokh M, Jalali S, Haghdoost AA, Abbott PV. Comparison of the effect of various irrigants on apically extruded debris after root canal preparation. J Endod. 2012 Feb;38(2):196-9. doi: 10.1016/j.joen.2011.10.027. Epub 2011 Dec 6.
- Individual participant dataSharing planned: Yes. outcome measures
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing passive ultrasonic activation and sonic activation in people with Irriversible Pulpitis and Irrigation, run by RANA AHMAD.
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 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: opening soon, as of the sponsor's last update on 29 Sep 2025. 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?
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?
pain score on visual analogue scale (time frame: 48 hours). 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 NCT07196215, which also lists 9 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 29 Sep 2025.