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

NCT ID: NCT02726737

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-10-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sodium bicarbonate

0.7 mL of 8.4% sodium bicarbonate \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

Group Type EXPERIMENTAL

sodium bicarbonate

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Non-sodium bicarbonate

Sterile distilled water \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

sterile distilled water

Intervention Type DRUG

Interventions

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sodium bicarbonate

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

sterile distilled water

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masoud Saatchi

OTHER

Sponsor Role lead

Responsible Party

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Masoud Saatchi

Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Masoud Saatchi

Role: STUDY_CHAIR

Isfahan University of Medical Sciences

Locations

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Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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941456

Identifier Type: -

Identifier Source: org_study_id

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