Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis

NCT02226913 | Completed Phase 3 DMC

• 1 other identifier: 193396
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Conditions

Local Anesthesia

Keywords

Buffered; inferior alveolar nerve block; irreversible pulpitis; local anesthesia; sodium bicarbonate

Outcome Measures

Primary Outcomes (1)

• Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block

  Baseline

Secondary Outcomes (1)

• Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block

  Baseline

Study Arms (2)

lidocaine & sodium bicarbonate

EXPERIMENTAL

2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate

Drug: 2% lidocaine with 1:80,000 epinephrine; Drug: sodium bicarbonate

lidocaine & placebo

ACTIVE COMPARATOR

2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water

Drug: 2% lidocaine with 1:80,000 epinephrine; Drug: placebo

Interventions

2% lidocaine with 1:80,000 epinephrine DRUG

2% lidocaine with 1:80,000 epinephrine

Also known as: Lignospan; Septodont, Saint Maur des Fosses, France

lidocaine & placebo; lidocaine & sodium bicarbonate

sodium bicarbonate DRUG

8.4% sodium bicarbonate

Also known as: Samen Laboratories (Mashhad, Iran)

lidocaine & sodium bicarbonate

placebo DRUG

sterile distilled water (Samen Pharmaceutical Co, Iran)

Also known as: sterile distilled water (Samen Pharmaceutical Co, Iran)

lidocaine & placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• vital mandibular molar tooth
• diagnosis of symptomatic irreversible pulpitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Masoud Saatchi: lead

MeSH Terms

Interventions

Lidocaine; Epinephrine; Septodont; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Masoud Saatchi, DDS MSc

  Isfahan University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: August 27, 2014
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share