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CompletedNCT02726737Updated Apr 5, 2016

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

A Phase 3 interventional study of sodium bicarbonate and Lidocaine in Local Anesthesia, sponsored by Masoud Saatchi. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-05.

Sponsored by Masoud Saatchi · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Local Anesthesia

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Keywords

  • inferior alveolar nerve block
  • irreversible pulpitis
  • local anesthesia
  • sodium bicarbonate
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 100 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Masoud Saatchi is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

Exclusion criteria

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
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Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    sodium bicarbonate

    0.7 mL of 8.4% sodium bicarbonate \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

    Drug: sodium bicarbonate · Drug: Lidocaine

  • Active comparator
    Non-sodium bicarbonate

    Sterile distilled water \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

    Drug: Lidocaine · Drug: sterile distilled water

Interventions

  • Drugsodium bicarbonate
  • DrugLidocaine
  • Drugsterile distilled water
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What researchers measure

Primary outcomes

  1. success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis

    Time frame: Baseline

Secondary outcomes

  1. Heft-Parker visual analog scale recording of pain

    Time frame: Baseline

07

Study locations

1 site
  • Isfahan University of Medical Sciences
    Isfahan, 81746-73461, Iran, Islamic Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02726737
Lead sponsor
Masoud Saatchi
Responsible party
Masoud Saatchi (Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Isfahan University of Medical Sciences) — Sponsor-investigator
First posted
Apr 4, 2016
Start date
Dec 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Apr 5, 2016

Study contacts

Masoud Saatchi
study chair · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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