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Trial record 2 of 7 for:    CASPIAN

Effect of Lidocaine/Dexamethasone on the Success of IANB (IANB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531970
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Local Anesthesia Drug: 2% lidocaine with 1:80,000 epinephrine Drug: Dexamethasone Drug: Placebo Phase 2 Phase 3

Detailed Description:
Several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. These investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. It is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : December 1, 2017


Arm Intervention/treatment
Experimental: Dexamethasone
lidocaine & Dexamethasone
Drug: 2% lidocaine with 1:80,000 epinephrine
Anesthetic solution
Other Name: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)

Drug: Dexamethasone
Corticostroide
Other Name: Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran)

Placebo Comparator: Non-dexamethasone
lidocaine & Placebo
Drug: 2% lidocaine with 1:80,000 epinephrine
Anesthetic solution
Other Name: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)

Drug: Placebo
Placebo
Other Name: sterile distilled water (Samen Pharmaceutical Co, Iran)




Primary Outcome Measures :
  1. success of IAN Block anesthesia for the Dexamethasone group [ Time Frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation) ]
    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.

  2. success of IAN Block anesthesia for the Non-dexamethasone group [ Time Frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation) ]
    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.


Secondary Outcome Measures :
  1. initial pain [ Time Frame: Baseline ]
    rating the pain on Heft-Parker visual analog scale. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531970


Locations
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Iran, Islamic Republic of
Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of, 8476890162
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Masoud Saatchi Isfahan University of Medical Sciences
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Responsible Party: Masoud Saatchi, DDS MSc, Professor of Endodontics, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03531970    
Other Study ID Numbers: 396731
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences:
inferior alveolar nerve block
irreversible pulpitis
local anesthesia
dexamethasone
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Dexamethasone
Dexamethasone acetate
Lidocaine
Epinephrine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers