NCT04119661

Brief Summary

The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

October 6, 2019

Last Update Submit

October 6, 2019

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain using a pain-measuring scale

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment

    4 hours

  • Postoperative pain using a pain-measuring scale

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment

    12 hours

  • Postoperative pain using a pain-measuring scale

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment

    24 hours

  • Postoperative pain using a pain-measuring scale

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment

    48 hours

Study Arms (2)

Max-i-Probe

EXPERIMENTAL
Device: Max-i-Probe

NaviTip

ACTIVE COMPARATOR
Device: NaviTip

Interventions

Max-i-ProbeDEVICE

Using Max-i-Probe as endodontic needle during syringe irrigation

Max-i-Probe
NaviTipDEVICE

Using NaviTip as endodontic needle during syringe irrigation

NaviTip

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 16-65 year old.
  • Medically free.
  • Mandibular posterior teeth with symptomatic irreversible pulpitis.
  • No sex predilection

You may not qualify if:

  • Pregnant females.
  • History of allergy to any medication used in the study.
  • Preoperative premedication less than 6 hours before procedure.
  • Cracked teeth and teeth with badly-decayed crowns.

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

Study Officials

  • Suzan Amin, Professor

    Cairo University

    STUDY DIRECTOR

  • Mohamed El-Bayoumi, Professor

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2019

First Posted

October 8, 2019

Study Start

July 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share