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

Phase 2

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Drug: bupivacaine plus mannitol; Drug: bupivacaine alone

• Registration Number: NCT03749408
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2018-11
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-17
• Last Update Submitted: 2018-11-20
• Study First Posted: 2018-11-21
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adult patients; age between 17-35 years old.
2. Males or Females.
3. Medically-free patients
4. Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
5. Positive patients' acceptance for participation in the study.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine plus mannitol	bupivacaine plus mannitol	0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol
bupivacaine alone	bupivacaine alone	0.5% bupivacaine with 1:200,000epinephrine alone

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain	72 hours	using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

Secondary Outcome Measures

Name	Time	Method
Anesthetic success	1 hour	yes or no
lip numbness duration	24 hours	recorded in hours
Medication intake	72 hours	yes or no