Effect of Lidocaine/Dexamethasone on the Success of IANB

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis

Conditions
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Local Anesthesia

Intervention / Treatment
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* Drug: 2% lidocaine with 1:80,000 epinephrine
* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>lidocaine & Dexamethasone | Drug: 2% lidocaine with 1:80,000 epinephrine<br>* Anesthetic solution<br>* Other names: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran);Drug: Dexamethasone<br>* Corticostroide<br>* Other names: Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran);|
| Placebo Comparator: Non-dexamethasone<br>lidocaine & Placebo | Drug: 2% lidocaine with 1:80,000 epinephrine<br>* Anesthetic solution<br>* Other names: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran);Drug: Placebo<br>* Placebo<br>* Other names: sterile distilled water (Samen Pharmaceutical Co, Iran);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial pain | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inferior alveolar nerve block, irreversible pulpitis, local anesthesia, dexamethasone