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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03749408

Enrollment

Registered

2018-11-21

Start date

2012-12-31

Completion date

2014-06-30

Last updated

2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

inferior alveolar nerve block, long-acting local anesthesia, bupivacaine, mannitol, symptomatic irreversible pulpitits

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.

Interventions

DRUGbupivacaine plus mannitol

local anesthesia

DRUGbupivacaine alone

local anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 35 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain	6 hours	using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026