Viewing Study NCT02536430



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Last Modification Date: 2024-10-26 @ 11:48 AM
Study NCT ID: NCT02536430
Status: COMPLETED
Last Update Posted: 2015-09-02
First Post: 2015-08-21

Brief Title: Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block
Sponsor: Nahid Mohammadzadeh Akhlaghi
Organization: Azad University of Medical Sciences

Study Overview

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
Status: COMPLETED
Status Verified Date: 2015-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 n20 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
Detailed 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 n20 All patients will receive standard inferior alveolar nerve block injection of 4 Articaine with 1100000 epinephrine and supplemental buccal infiltration of 09 mL 4 Articaine with 1100000 epinephrine After five minutes when the lip numbness was achieved one group received supplemental buccal infiltration of 30 mgmL 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None