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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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bupivacaine plus mannitol

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

Group Type ACTIVE_COMPARATOR

bupivacaine plus mannitol

Intervention Type DRUG

local anesthesia

bupivacaine alone

0.5% bupivacaine with 1:200,000epinephrine alone

Group Type EXPERIMENTAL

bupivacaine alone

Intervention Type DRUG

local anesthesia

Interventions

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bupivacaine plus mannitol

local anesthesia

Intervention Type DRUG

bupivacaine alone

local anesthesia

Intervention Type DRUG

Other Intervention Names

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vivacaine plus mannitol vivacaine

Eligibility Criteria

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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.

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.

Minimum Eligible Age

17 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No