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

November 20, 2018 updated by: Safeya AbdelRahaman Hassan, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients; age between 17-35 years old.
  2. Males or Females.
  3. Medically-free patients
  4. Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bupivacaine plus mannitol
0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol
Drug: bupivacaine plus mannitol
local anesthesia
Other Names:
  • vivacaine plus mannitol
Experimental: bupivacaine alone
0.5% bupivacaine with 1:200,000epinephrine alone
Drug: bupivacaine alone
local anesthesia
Other Names:
  • vivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 hours
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
12 hours
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
24 hours
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
48 hours
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
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic success
Time Frame: 1 hour
yes or no
1 hour
lip numbness duration
Time Frame: 24 hours
recorded in hours
24 hours
Medication intake
Time Frame: 72 hours
yes or no
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 17, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2012-12-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irreversible Pulpitis

Clinical Trials on bupivacaine plus mannitol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe