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

NCT ID: NCT02913937

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Needle irrigation

Endodontic irrigation will be done using an endodontic needle.

Group Type ACTIVE_COMPARATOR

Endodontic needle

Intervention Type DEVICE

Endodontic irrigation

Passive ultrasonic irrigation

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

Group Type EXPERIMENTAL

Passive ultrasonic irrigation

Intervention Type DEVICE

Endodontic irrigation followed by passive ultrasonic agitation.

Interventions

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Passive ultrasonic irrigation

Endodontic irrigation followed by passive ultrasonic agitation.

Intervention Type DEVICE

Endodontic needle

Endodontic irrigation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Tawfik aly

postgraduate student, Department of Endodontics, Cairo University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randa El-Bogdady

Role: STUDY_DIRECTOR

Cairo University

Suzan AW Amin

Role: STUDY_CHAIR

Cairo University

Central Contacts

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Noha aly, Postgraduate

Role: CONTACT

01015011128

References

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Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

Reference Type BACKGROUND
PMID: 20647083 (View on PubMed)

Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.

Reference Type BACKGROUND
PMID: 27248848 (View on PubMed)

Other Identifiers

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CEBD-CU-2016-09-201

Identifier Type: -

Identifier Source: org_study_id

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