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Completed

NCT Number: NCT03749408

Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain

Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.

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Key information

Conditions

Irreversible Pulpitis

Age range

17 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients; age between 17-35 years old.
  • Males or Females.
  • Medically-free patients
  • Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
  • Positive patients' acceptance for participation in the study.

Exclusion criteria

  • Patients who had any analgesic during proceeding 12 hours before the treatment.
  • Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
  • Pregnant females.
  • Patients with history of significant medical conditions (contraindication of mannitol use).
  • Addiction
  • Psycological disturbance.

Treatment and study plan

bupivacaine plus mannitol

Drug

local anesthesia

Other names: vivacaine plus mannitol

bupivacaine alone

Drug

local anesthesia

Other names: vivacaine

Primary outcomes

  1. Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain

    Time frame: 6 hours

    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

  2. Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain

    Time frame: 12 hours

    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

  3. Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain

    Time frame: 24 hours

    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

  4. Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain

    Time frame: 48 hours

    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

  5. Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain

    Time frame: 72 hours

    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

Secondary outcomes

  1. Anesthetic success

    Time frame: 1 hour

    yes or no

  2. lip numbness duration

    Time frame: 24 hours

    recorded in hours

  3. Medication intake

    Time frame: 72 hours

    yes or no

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2018
Registry last updated
Nov 23, 2018

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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