NCT02913937

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 9, 2017

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

September 22, 2016

Last Update Submit

February 7, 2017

Conditions

Apical Periodontitis

Keywords

ultrasonic irrigationpainhealingapical periodontitis

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

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

    7 days

Secondary Outcomes (1)

  • Periapical healing

    12 months

Study Arms (2)

Needle irrigation

ACTIVE COMPARATOR

Endodontic irrigation will be done using an endodontic needle.

Device: Endodontic needle

Passive ultrasonic irrigation

EXPERIMENTAL

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

Device: Passive ultrasonic irrigation

Interventions

Passive ultrasonic irrigationDEVICE

Endodontic irrigation followed by passive ultrasonic agitation.

Passive ultrasonic irrigation
Endodontic needleDEVICE

Endodontic irrigation

Needle irrigation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20647083BACKGROUND

  • 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.

    PMID: 27248848BACKGROUND

MeSH Terms

Conditions

Periapical PeriodontitisPain

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Randa El-Bogdady

    Cairo University

    STUDY DIRECTOR

  • Suzan AW Amin

    Cairo University

    STUDY CHAIR

Central Study Contacts

Noha aly, Postgraduate

CONTACT

01015011128nohatawfik26@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate student, Department of Endodontics, Cairo University.

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

February 1, 2017

Primary Completion

February 1, 2018

Study Completion

January 1, 2019

Last Updated

February 9, 2017

Record last verified: 2016-10