Comparison of Post-operative Pain After Different Root Canal Irrigant Activation Methods

NCT07196215 | Not Yet Recruiting DMC

• 1 other identifier: TUF/IRB/21/25
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

root canal irrigation protocol

Conditions

Irriversible Pulpitis; Irrigation; Activation, Patient

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Study Arms (2)

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.

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

Procedure: sonic activation

Interventions

passive ultrasonic activation PROCEDURE

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

Passive ultrasonic activation

sonic activation PROCEDURE

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

Sonic activation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RANA AHMAD: lead

Related Publications (9)

• 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.

  PMID: 32915346 BACKGROUND

• Narla 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.

  PMID: 38098913 BACKGROUND

• 7. 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39205753 BACKGROUND

• 3. 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.

  BACKGROUND

• 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.

  PMID: 17956561 BACKGROUND

• Parirokh 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.

  PMID: 22244635 BACKGROUND

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: start date: august 2027 end date: december 2027
• Access Criteria: principal investigator will have access by contacting corresponding author