Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block

April 1, 2016 updated by: Masoud Saatchi

Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in the Mandibular First Molar With Symptomatic Irreversible Pulpitis: a Prospective, Randomized Double-blind Study

The purpose of this prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies have been done by adding Sodium Bicarbonate to local anesthesia in dentistry based on the theory that the amount of local anesthetic in the free-base un-ionized form will decrease to provide greater lipid penetration of the nerve and this could be cause of the failure of local anesthesia injected into the inflamed tissue with low PH and conflicting results were obtained. But, there are no study that evaluate effect of increasing PH in periradicular tissue on hindrance of resistance channels with supplementary infiltration injection of Sodium Bicarbonate

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

  • younger than 18 years old
  • history of significant medical conditions
  • allergies to local anesthetics or sulfites
  • pregnancy
  • taking any medications that might influence anesthetic assessment
  • active sites of pathosis in area of injection
  • inability to give informed consent

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: sodium bicarbonate
0.7 mL of 8.4% sodium bicarbonate & 0.3 mL of 2% lidocaine with 1:100,000 epinephrine
Drug: Lidocaine
Drug: sodium bicarbonate
ACTIVE_COMPARATOR: Non-sodium bicarbonate
Sterile distilled water & 0.3 mL of 2% lidocaine with 1:100,000 epinephrine
Drug: Lidocaine
Drug: sterile distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Heft-Parker visual analog scale recording of pain
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Masoud Saatchi

Investigators

  • Study Chair: Masoud Saatchi, Isfahan University of Medical Sciences

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

December 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

April 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 941456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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