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

Cairo University (CU)

Status: Unknown

Conditions: Apical Periodontitis

Treatments: Device: Endodontic needle; Device: Passive ultrasonic irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02913937

CEBD-CU-2016-09-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Needle irrigation

Active Comparator group

Description:

Endodontic irrigation will be done using an endodontic needle.

Treatment:

Device: Endodontic needle

Passive ultrasonic irrigation

Experimental group

Description:

Endodontic passive ultrasonic irrigation will be done using an endodontic needle followed by passive ultrasonic agitation.

Treatment:

Device: Passive ultrasonic irrigation