NCT02726737

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
Last Updated

April 5, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

March 30, 2016

Last Update Submit

April 1, 2016

Conditions

Local Anesthesia

Keywords

inferior alveolar nerve blockirreversible pulpitislocal anesthesiasodium bicarbonate

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Secondary Outcomes (1)

  • Heft-Parker visual analog scale recording of pain

    Baseline

Study Arms (2)

sodium bicarbonate

EXPERIMENTAL

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

Drug: sodium bicarbonateDrug: Lidocaine

Non-sodium bicarbonate

ACTIVE COMPARATOR

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

Drug: LidocaineDrug: sterile distilled water

Interventions

sodium bicarbonateDRUG
sodium bicarbonate
LidocaineDRUG
Non-sodium bicarbonatesodium bicarbonate
sterile distilled waterDRUG
Non-sodium bicarbonate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, 81746-73461, Iran

Location

MeSH Terms

Interventions

Sodium BicarbonateLidocaine

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Masoud Saatchi

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 4, 2016

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 5, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)