ClinicalTrials.gg
CompletedNCT04119661Updated Oct 8, 2019

Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles

An interventional study of Max-i-Probe and NaviTip in Symptomatic Irreversible Pulpitis, sponsored by Cairo University. Completed. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-08.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 years 3 months after the study started (first participant enrolled Jul 2012, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.

02

Conditions studied

  • Symptomatic Irreversible Pulpitis
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnant females.
  2. History of allergy to any medication used in the study.
  3. Preoperative premedication less than 6 hours before procedure.
  4. Cracked teeth and teeth with badly-decayed crowns.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Max-i-Probe

    Device: Max-i-Probe

  • Active comparator
    NaviTip

    Device: NaviTip

Interventions

  • DeviceMax-i-Probe

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

  • DeviceNaviTip

    Using NaviTip as endodontic needle during syringe irrigation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 hours

  2. 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

    Time frame: 12 hours

  3. 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

    Time frame: 24 hours

  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 48h after root canal treatment

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 20647083 ↗
  • 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. PubMed 27248848 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2012 to primary completion in May 2015, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2019
First posted
Oct 8, 2019
StartActual
Jul 2012
Primary completionActual
May 2015
CompletionActual
May 2015
Last update
Oct 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04119661
Lead sponsor
Cairo University
Responsible party
Suzan AW Amin (Professor, Cairo University) — Principal investigator
First posted
Oct 8, 2019
Start date
Jul 2012
Primary completion
May 2015
Completion
May 2015
Last update
Oct 8, 2019

Study contacts

Suzan Amin, Professor
study director · Cairo University
Mohamed El-Bayoumi, Professor
study chair · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion