NCT03531970

Brief Summary

The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

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

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 2, 2018

Last Update Submit

May 18, 2018

Conditions

Local Anesthesia

Keywords

inferior alveolar nerve blockirreversible pulpitislocal anesthesiadexamethasone

Outcome Measures

Primary Outcomes (2)

  • success of IAN Block anesthesia for the Dexamethasone group

    The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as \>0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.

    15 minutes after the local anesthetic injection (at time of access cavity preparation)

  • success of IAN Block anesthesia for the Non-dexamethasone group

    The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as \>0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.

    15 minutes after the local anesthetic injection (at time of access cavity preparation)

Secondary Outcomes (1)

  • initial pain

    Baseline

Study Arms (2)

Dexamethasone

EXPERIMENTAL

lidocaine \& Dexamethasone

Drug: 2% lidocaine with 1:80,000 epinephrineDrug: Dexamethasone

Non-dexamethasone

PLACEBO COMPARATOR

lidocaine \& Placebo

Drug: 2% lidocaine with 1:80,000 epinephrineDrug: Placebo

Interventions

2% lidocaine with 1:80,000 epinephrineDRUG

Anesthetic solution

Also known as: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)
DexamethasoneNon-dexamethasone
DexamethasoneDRUG

Corticostroide

Also known as: Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran)
Dexamethasone
PlaceboDRUG

Placebo

Also known as: sterile distilled water (Samen Pharmaceutical Co, Iran)
Non-dexamethasone

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, 8476890162, Iran

Location

MeSH Terms

Interventions

LidocaineEpinephrineDexamethasone

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Masoud Saatchi

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endodontics

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 22, 2018

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)