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

Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749408
• Other study ID #: CEBD-CU-2012-12-24
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Drug:
• bupivacaine plus mannitol
local anesthesia
• bupivacaine alone
local anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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