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Comparison and effect of activation irrigation with Ultra X device , Wave Q device and conventional irrigation of root canal with endodontic needle on postoperative endodontic pain

Protocol summary

Study aim
The aim of this study was to evaluate and compare the effects of irrigant activation using the WaveQ device, the Ultra X device, and conventional syringe-and-needle irrigation on postoperative pain following root canal treatme
Design
This study was a phase III, randomized, double-blind, controlled clinical trial with parallel groups conducted on 39 patients. Eligible patients were ran/domly assigned to one of the three study groups (Groups 1, 2, 3)
Settings and conduct
Patients referred to the Endodontics Department of Islamic Azad University, Khorasgan Branch, who are candidates for root canal treatment of mandibular premolars and meet the inclusion criteria of the study, will be randomly assigned to one of the three groups (1, 2, or 3) after providing a full explanation of the study and obtaining written informed consent. Post-treatment pain intensity will be measured at 6, 12, 24, 48, and 72 hours, as well as one week after completion of treatment, using the Visual Analogue Scale (VAS).
Participants/Inclusion and exclusion criteria
In this randomized clinical trial, 39 patients with symptomatic irreversible pulpitis of mandibular premolars (Visual Analogue Scale ≥54) were enrolled. Following local anesthesia and isolation, canals were prepared to size F2 using rotary files, with 5.25% sodium hypochlorite (NaOCl) irrigation between each file. Patients were randomly assigned to three groups (n=13): Ultra X, Wave Q, and conventional needle irrigation. After single-visit obturation (gutta-percha/AH26) and temporary restoration, pain intensity was recorded via VAS at 6, 12, 24, 48, 72 hours, and 1 week. Data were analyzed using Kruskal–Wallis, Friedman, Chi-square/Fisher’s exact and Mann–Whitney U tests.
Intervention groups
1. using endodontic needle 2.activation with sonic device 3. activation with ultrasonic device
Main outcome variables
endodontic post operative pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260615069816N1
Registration date: 2026-06-27, 1405/04/06
Registration timing: retrospective

Last update: 2026-06-27, 1405/04/06
Update count: 0
Registration date
2026-06-27, 1405/04/06
Registrant information
Name
Zahra Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7731 9048
Email address
zmhmmdi1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-25, 1404/07/03
Expected recruitment end date
2026-04-15, 1405/01/26
Actual recruitment start date
2025-09-25, 1404/07/03
Actual recruitment end date
2026-04-15, 1405/01/26
Trial completion date
empty
Scientific title
Comparison and effect of activation irrigation with Ultra X device , Wave Q device and conventional irrigation of root canal with endodontic needle on postoperative endodontic pain
Public title
Comparison and effect of activation irrigation solution on postoperative endodontic pain
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients with good systemic health and no significant medical conditions (ASA I or II).2. Patients diagnosed with irreversible pulpitis with spontaneous pain and symptomatic apical periodontitis in single-rooted, single-canal premolar teeth.3. Patients capable of understanding the Visual Analog Scale (VAS) for pain assessment.4. Patients aged between 18 and 55 years.5. Patients who are willing to participate in the study and are able to provide written informed consent.6. Patients who are candidates for single-visit endodontic treatment
Exclusion criteria:
1. Patients with systemic diseases.2. Pregnant women and breastfeeding mothers.3. Patients requiring antibiotic prophylaxis.4. Patients with psychiatric disorders.5. Patients with a history of allergy to the medications or materials used in the study.6. Patients who had taken antibiotics or analgesics within 12 hours prior to treatment.7. Patients with a current or previous history of abscess formation or swelling in the periapical region.8. Teeth presenting any of the following conditions were excluded from the study: - Open apex or a wide apical foramen. - Necrotic teeth. - Presence of a fistula or sinus tract. - Acute or chronic periapical abscess. - Teeth with Grade II or III mobility. - Non-restorable or hopeless teeth. - Abnormal root canal anatomy or calcified canals.9. Teeth in which procedural errors occurred during root canal treatment.10. Teeth in which apical patency could not be established.11. Patients who developed a flare-up following treatment.12. Patients with stress, as determined by the stress assessment test
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 39
Actual sample size reached: 39
Randomization (investigator's opinion)
Randomized
Randomization description
The methodology section has been revised to provide detailed clarification regarding participant allocation. Randomization was performed using a simple lottery-based allocation method with opaque folded papers corresponding to each intervention group. Allocation was conducted prior to the irrigation procedure to minimize selection bias
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was designed as a single-blind randomized clinical trial in which the patients were unaware of the irrigation activation method used during treatment. Due to the nature of the intervention, operator blinding was not feasible
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azad Islamic University Khorasgan branch
Street address
Daneshgah Blvd , Arghavanie , east jey avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81595158
Approval date
2025-06-21, 1404/03/31
Ethics committee reference number
IR.IAU.KHUISF.REC.1404.235

Health conditions studied

1

Description of health condition studied
Post operative pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
post operative pain
Timepoint
6, 12, 24, 48 , 72 hour and 1 week after treatment
Method of measurement
VAS pain score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: type of activation irrigation solution
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
dentistry school of Azad Islamic university (khorasgan branch)
Full name of responsible person
maryam zare jahromi
Street address
Daneshgah Blvd , arghavanie , east Jey street , Isfahan
City
isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam zare jahromi
Street address
Daneshgah Blvd, arghaavnie , east Jey street , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam zare jahromi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Blvd , Arghavanie , east Jey street , Isfahan
City
isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 21 7731 9048
Email
hiva1378maryam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
zahra mohammadi
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 6, Yas avenue , Pormokhtar avenue , Bahar Blvd , Hakimiye , Tehran
City
tehran
Province
Tehran
Postal code
1695945866
Phone
+98 21 7731 9048
Email
zmhmmdi1997@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra mohammadi
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 6. Yas steet ,Pormokhtar street , Bahar Blvd , Hakimiye , Tehran
City
اصفهان
Province
Tehran
Postal code
1695945866
Phone
+98 21 7731 9048
Email
zmhmmdi1997@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
post operative pain
When the data will become available and for how long
1 year after publication
To whom data/document is available
dentists
Under which criteria data/document could be used
for more research
From where data/document is obtainable
researcher
What processes are involved for a request to access data/document
6 month
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