NCT02912286

Brief Summary

The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

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
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 20, 2016

Last Update Submit

September 22, 2016

Conditions

Tooth,Non-vital

Outcome Measures

Primary Outcomes (1)

  • postoperative pain measured by numerical rate scale

    Numerical rate scale (NRS) consists of a line graded from 0-10 where 0 indicates no pain and 10 indicates worst pain, patient will choose the number that describe his pain level.

    4 hours after treatment

Study Arms (3)

conventional needle irrigation

ACTIVE COMPARATOR

side-vented needle used for endodontic irrigation

Device: conventional needle irrigation

passive ultrasonic irrigation

EXPERIMENTAL

IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment

Device: passive ultrasonic irrigation

sonic irrigation

EXPERIMENTAL

Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time

Device: sonic irrigation

Interventions

conventional needle irrigationDEVICE

conventional side-vented syringe used to deliver irrigant in root canal treatment

conventional needle irrigation
passive ultrasonic irrigationDEVICE

ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment

passive ultrasonic irrigation
sonic irrigationDEVICE

vibringe system is a sonic device that deliver and agitate the irrigant

sonic irrigation

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males or Females
  • Age between 16-60 years old
  • Permanent Mandibular molars with:
  • Non-vital response of pulp tissue
  • Absence of spontaneous pain

You may not qualify if:

  • Pregnant females
  • Patients having significant systemic disorder
  • Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours
  • Teeth that have:
  • Vital pulp tissues
  • Association with swelling or fistulous tract
  • Acute periapical abscess
  • Greater than grade I mobility
  • Pocket depth greater than 5mm
  • Previous endodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Assisstant lecturer

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 23, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

September 23, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share