Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block

Failed Mechanical Induction Clinical Trial

Official title:

Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536430
• Other study ID #: AZadUMS-P/212/D
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2015
• Last updated: September 1, 2015
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Description:

Objectives:

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.

Design: Randomized double blind clinical trial

Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration

Main outcome measures : Pain during caries and dentin removal , access cavity preparation and canals length measurements using VAS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with age ranged 18-65;

• without systemic diseases;

• without any medicine consumption;

• non smoking;

• non pregnant;

• non breast feeding;

• with symptomatic irreversible pulpitis (Visual Analog Scale = 54) in one mandibular molar that needs root canal treatment

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failed Mechanical Induction

Intervention

Drug:
• Ketorolac Tromethamine
One group received a buccal infiltration of Ketorolac Tromethamine
• Placebo
buccal infiltration of Normal Saline.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental Branch, AZad UMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Nahid Mohammadzadeh Akhlaghi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block		One week	No