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

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ClinicalTrials.gov Identifier: NCT02226913
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Masoud Saatchi, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Local Anesthesia Drug: 2% lidocaine with 1:80,000 epinephrine Drug: sodium bicarbonate Drug: placebo Phase 3

Detailed Description:
Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study
Study Start Date : February 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lidocaine & sodium bicarbonate
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
2% lidocaine with 1:80,000 epinephrine
Other Name: Lignospan; Septodont, Saint Maur des Fosses, France

Drug: sodium bicarbonate
8.4% sodium bicarbonate
Other Name: Samen Laboratories (Mashhad, Iran)

Active Comparator: lidocaine & placebo
2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water
Drug: 2% lidocaine with 1:80,000 epinephrine
2% lidocaine with 1:80,000 epinephrine
Other Name: Lignospan; Septodont, Saint Maur des Fosses, France

Drug: placebo
sterile distilled water (Samen Pharmaceutical Co, Iran)
Other Name: sterile distilled water (Samen Pharmaceutical Co, Iran)




Primary Outcome Measures :
  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 [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226913


Sponsors and Collaborators
Masoud Saatchi
Investigators
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Study Chair: Masoud Saatchi, DDS MSc Isfahan University of Medical Sciences
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Responsible Party: Masoud Saatchi, associate professor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02226913    
Other Study ID Numbers: 193396
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Masoud Saatchi, Isfahan University of Medical Sciences:
Buffered
inferior alveolar nerve block
irreversible pulpitis
local anesthesia
sodium bicarbonate
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Lidocaine
Epinephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents