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

Primary Purpose

Apical Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Passive ultrasonic irrigation

Endodontic needle

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring ultrasonic irrigation, pain, healing, apical periodontitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Needle irrigation

Passive ultrasonic irrigation

Arm Description

Endodontic irrigation will be done using an endodontic needle.

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

Outcomes

Primary Outcome Measures

Postoperative pain

postoperative pain will be assessed using numerical rate scale (NRS).

Secondary Outcome Measures

Periapical healing

Periapical healing will be assessed using periapical index (PAI).

Full Information

NCT ID

NCT02913937

First Posted

September 22, 2016

Last Updated

February 7, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02913937

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2017 (Anticipated)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apical Periodontitis

Keywords

ultrasonic irrigation, pain, healing, apical periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Needle irrigation

Arm Type

Active Comparator

Arm Description

Endodontic irrigation will be done using an endodontic needle.

Arm Title

Passive ultrasonic irrigation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Passive ultrasonic irrigation

Intervention Description

Endodontic irrigation followed by passive ultrasonic agitation.

Intervention Type

Device

Intervention Name(s)

Endodontic needle

Intervention Description

Endodontic irrigation

Primary Outcome Measure Information:

Title

Postoperative pain

Description

postoperative pain will be assessed using numerical rate scale (NRS).

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Periapical healing

Description

Periapical healing will be assessed using periapical index (PAI).

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noha aly, Postgraduate

Phone

01015011128

nohatawfik26@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randa El-Bogdady

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Suzan AW Amin

Organizational Affiliation

Cairo University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

20647083

Citation

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.

Results Reference

background

PubMed Identifier

27248848

Citation

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.

Results Reference

background

Learn more about this trial

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

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