Effect of Passive Ultrasonic Irrigation Versus Needle Irrigation on Postoperative Pain and Periapical Healing

Comparison of Postoperative Pain and Healing After Passive Ultrasonic Irrigation and Needle Irrigation in Patients With Apical Periodontitis: A Randomized Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02913937

Enrollment

Registered

2016-09-26

Start date

2017-02-28

Completion date

2019-01-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis

Keywords

ultrasonic irrigation, pain, healing, apical periodontitis

Brief summary

The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.

Detailed description

Full medical and dental history using a dental chart for all patients treated in this study. Clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter. The treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. Endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and Endo-Z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. During mechanical preparation, irrigation will be done using passive ultrasonic irrigation (Experimental group) where ultrasonic activation will be done for irrigant-filled canals using the U- file tip (Varios NSK) in an ultrasonic device (P5 Newtron; Satelec Acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (Control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.

Interventions

DEVICEPassive ultrasonic irrigation

Endodontic irrigation followed by passive ultrasonic agitation.

DEVICEEndodontic needle

Endodontic irrigation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 18-55 years old. * Males and females. * Positive patient's acceptance to participate in the study. * Mature, permanent, mandibular, posterior teeth with apical periodontitis.

Exclusion criteria

* Medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy. * Patients who had received analgesic treatment recently (past 8 hours) as it can affect the results * Pregnant females. * Teeth with previous root canal treatment.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	7 days	postoperative pain will be assessed using numerical rate scale (NRS).

Secondary

Measure	Time frame	Description
Periapical healing	12 months	Periapical healing will be assessed using periapical index (PAI).

Contacts

Primary ContactNoha aly, Postgraduate

nohatawfik26@hotmail.com01015011128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026