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

NCT03749408 | Completed Phase 2

• 1 other identifier: CEBD-CU-2012-12-24
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irreversible Pulpitis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Anesthetic success

  1 hour

• lip numbness duration

  24 hours

• Medication intake

  72 hours

Study Arms (2)

bupivacaine plus mannitol

ACTIVE COMPARATOR

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

Drug: bupivacaine plus mannitol

bupivacaine alone

EXPERIMENTAL

0.5% bupivacaine with 1:200,000epinephrine alone

Drug: bupivacaine alone

Interventions

bupivacaine plus mannitol DRUG

local anesthesia

Also known as: vivacaine plus mannitol

bupivacaine plus mannitol

bupivacaine alone DRUG

local anesthesia

Also known as: vivacaine

bupivacaine alone

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Bupivacaine; Mannitol

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sugar Alcohols; Alcohols; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 21, 2018
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share