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Completed

NCT Number: NCT04119661

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

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.

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Key information

Conditions

Symptomatic Irreversible Pulpitis

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Max-i-Probe

Device

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

NaviTip

Device

Using NaviTip as endodontic needle during syringe irrigation

Primary outcomes

  1. Postoperative pain using a pain-measuring scale

    Time frame: 4 hours

    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

  2. Postoperative pain using a pain-measuring scale

    Time frame: 12 hours

    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

  3. Postoperative pain using a pain-measuring scale

    Time frame: 24 hours

    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

  4. Postoperative pain using a pain-measuring scale

    Time frame: 48 hours

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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