ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000533493

Ethics application status

Approved

Date submitted

5/02/2025

Date registered

27/05/2025

Date last updated

27/05/2025

Date data sharing statement initially provided

27/05/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of Post-Operative Pain after Root Canal Treatment Using Passive Irrigation and Ultrasonic Activation Technique: A Randomized Controlled Trial

Scientific title

Comparison of Post-Operative Pain after Root Canal Treatment Using Passive Irrigation and Ultrasonic Activation Technique: A Randomized Controlled Clinical Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-Operative Pain after Root Canal Treatment

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Ultrasonic activation is presently the most popular irrigant activation method and the second most popular irrigation method. In our study, 5.25% Sodium hypochlorite will be the irrigant used to clean and disinfect the root canal system.
Ultrasonically activated irrigation (UAI) implies the ultrasonic activation of irrigant in the center of the instrumented root canal by a non-cutting, oscillating instrument.
The working mechanism primarily is the generation of steady, unidirectional circulation of fluid in the vicinity of the vibrating instrument, called acoustic microstreaming. Nonetheless, transient cavitation has also been observed within the root canal confinement during UAI.
Following cleaning and shaping of the root canal system, Ultra X activator tip will be selected and fits passively when placed 2-3 mm short of working length. The solution will then be agitated using short vertical strokes for around 30 seconds.
The procedure will be performed by a post graduate dental student, who is qualified and trained in the specialization of Endodontics.
To assess the adherence to the intervention, a pre-procedural checklist is prepared after consent from a specialist Endodontist, which is standardised based on recent guidelines.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Sodium Hypochlorite (NaOCl) is the main irrigant solution for disinfecting during root canal treatment. NaOCl solution is known as the gold standard for cleaning and irrigation root canal systems.
Primarily Irrigation with a syringe and a metal needle is the most common method used for irrigation within the root canal space.

Control group

Active

Outcomes

Primary outcome [1]

Post operative pain

Timepoint [1]

6 hours, 24 hours, 3 days and 7 days after completion of root canal treatment

Secondary outcome [1]

nil

Timepoint [1]

nil

Eligibility

Key inclusion criteria

Patients should be more than 18 years of age.
Lower Premolar teeth that are diagnosed with pulp necrosis or Symptomatic or Asymptomatic irreversible pulpitis with healthy periapex;
Should not have taken any antibiotics, anti-inflammatories, or analgesics for at least 12h hours before the treatment.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients refusing to participate in the study,
Patients with immunosuppression or immunocompromised condition and systemic diseases;
Pregnant or lactating female patients;
Psychologically disturbed patients;
Patients allergic to any sort of medications used in this clinical trial
Tooth associated with
swelling or acute periapical abscess/lesions,
immature tooth
Impossible restorability
Abnormal anatomy or calcified canals
Previous root canal treatments
Cracked tooth
Grade 2 or 3 mobility of tooth
Patients that administered anti-inflammatory analgesics or antibiotics 12 hours preoperatively

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Non-Parametric Test: Mann Whitney Test

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

16/06/2025

Actual

Date of last participant enrolment

Anticipated

29/08/2025

Actual

Date of last data collection

Anticipated

26/09/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Selangor

Funding & Sponsors

Funding source category [1]

University

Name [1]

MAHSA University

Address [1]

Country [1]

Malaysia

Primary sponsor type

University

Name

MAHSA University

Address

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MAHSA University Human Ethics Committee

Ethics committee address [1]

MAHSA University Human Ethics Committee, MAHSA University, Jln SP 2, Bandar Saujana Putra, 42610 Jenjarom, Selangor, Malaysia. Contact Number:  +601121057022

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

01/10/2024

Approval date [1]

18/10/2024

Ethics approval number [1]

Summary

Brief summary

This study is a clinical based research on comparison of post-operative pain after root canal treatment using passive irrigation and ultrasonic activation techniques. The study's aim is to determine whether there is a difference in the postoperative pain after using passive irrigation and ultrasonic activation of sodium hypochlorite. The anticipated results of this research include gaining an enhanced understanding of the difference between the severity of post-operative pain after using passive irrigation and Ultrasonic activation of sodium hypochlorite as an irrigating material during root canal treatment of lower premolar teeth, which may help in decreasing postoperative pain of the patients and performing more successful root canal treatments in the future.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Philip Pradeep

Address

MAHSA University, Jalan SP 2, Bandar Saujana Putra, 42610, Jenjarom, Selangor

Country

Malaysia

Phone

+60165153342

Fax

[email protected]

Contact person for public queries

Name

Philip Pradeep

Address

MAHSA University, Jalan SP 2, Bandar Saujana Putra, 42610, Jenjarom, Selangor

Country

Malaysia

Phone

+60165153342

Fax

[email protected]

Contact person for scientific queries

Name

Philip Pradeep

Address

MAHSA University, Jalan SP 2, Bandar Saujana Putra, 42610, Jenjarom, Selangor

Country

Malaysia

Phone

+60165153342

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24512	Ethical approval				ethical approval certificate	OCT24 EC01 Dr Kamand.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically