Trial | NCT02226913  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
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.
Study Started
Feb 28
2013
Primary Completion
Sep 30
2013
Study Completion
Sep 30
2013
Last Update
Aug 31
2016
Estimate

Drug 2% lidocaine with 1:80,000 epinephrine

2% lidocaine with 1:80,000 epinephrine

  • Other names: Lignospan; Septodont, Saint Maur des Fosses, France

Drug sodium bicarbonate

8.4% sodium bicarbonate

  • Other names: Samen Laboratories (Mashhad, Iran)

Drug placebo

sterile distilled water (Samen Pharmaceutical Co, Iran)

  • Other names: sterile distilled water (Samen Pharmaceutical Co, Iran)

lidocaine & sodium bicarbonate Experimental

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

lidocaine & placebo Active Comparator

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

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
No Results Posted