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Completed

NCT Number: NCT02226913

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

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.

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Key information

Conditions

Local Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% lidocaine with 1:80,000 epinephrine

Drug

2% lidocaine with 1:80,000 epinephrine

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

Sodium bicarbonate

Drug

8.4% sodium bicarbonate

Other names: Samen Laboratories (Mashhad, Iran)

Placebo

Drug

sterile distilled water (Samen Pharmaceutical Co, Iran)

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

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

    Time frame: 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

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Masoud Saatchi

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2014
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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