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

• ClinicalTrials.gov Identifier: NCT03531970
• Recruitment Status: Completed
• First Posted: May 22, 2018
• Last Update Posted: May 22, 2018
• Sponsor: Isfahan University of Medical Sciences
• Information provided by (Responsible Party): Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences

Study Description

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Iran, Islamic Republic of

Isfahan University of Medical Sciences

Isfahan, Iran, Islamic Republic of, 8476890162

Sponsors and Collaborators

Isfahan University of Medical Sciences

Investigators

• Principal Investigator: Masoud Saatchi; Isfahan University of Medical Sciences

More Information

• 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
• Last Update Posted: May 22, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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