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

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726737
• Other study ID #: 941456
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2016
• Last updated: April 1, 2016
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Drug:
• sodium bicarbonate

• Lidocaine

• sterile distilled water

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Masoud Saatchi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis		Baseline	Yes
Secondary	Heft-Parker visual analog scale recording of pain		Baseline	Yes