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

Phase 3

Completed

• Conditions: Local Anesthesia
• Interventions: Drug: Lidocaine; Drug: sodium bicarbonate; Drug: sterile distilled water

• Registration Number: NCT02726737
• Lead Sponsor: Masoud Saatchi

Brief 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

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-02
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-04-01
• Study First Posted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-sodium bicarbonate	sterile distilled water	Sterile distilled water \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine
Non-sodium bicarbonate	Lidocaine	Sterile distilled water \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine
sodium bicarbonate	sodium bicarbonate	0.7 mL of 8.4% sodium bicarbonate \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine
sodium bicarbonate	Lidocaine	0.7 mL of 8.4% sodium bicarbonate \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

Primary Outcome Measures

Name	Time	Method
success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis	Baseline

Secondary Outcome Measures

Name	Time	Method
Heft-Parker visual analog scale recording of pain	Baseline

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of