Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain

Study Overview
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Brief Summary
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Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.

Detailed Description
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Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.

Official Title
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Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Drug: bupivacaine plus mannitol
* Drug: bupivacaine alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients; age between 17-35 years old. Males or Females. Medically-free patients Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth. Positive patients' acceptance for participation in the study. Exclusion Criteria: Patients who had any analgesic during proceeding 12 hours before the treatment. Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess). Pregnant females. Patients with history of significant medical conditions (contraindication of mannitol use). Addiction Psycological disturbance.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine plus mannitol<br>0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol | Drug: bupivacaine plus mannitol<br>* local anesthesia<br>* Other names: vivacaine plus mannitol;|
| Experimental: bupivacaine alone<br>0.5% bupivacaine with 1:200,000epinephrine alone | Drug: bupivacaine alone<br>* local anesthesia<br>* Other names: vivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain | using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain | 6 hours | 
| Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain | using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain | 12 hours | 
| Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain | using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain | 24 hours | 
| Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain | using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain | 48 hours | 
| Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain | using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic success | yes or no | 1 hour | 
| lip numbness duration | recorded in hours | 24 hours | 
| Medication intake | yes or no | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inferior alveolar nerve block, long-acting local anesthesia, bupivacaine, mannitol, symptomatic irreversible pulpitits