Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03410212
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2018-01-04
Brief Title:
Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain
Sponsor:
Azad University of Medical Sciences
Organization:
Azad University of Medical Sciences
Study Overview
Official Title:
Efficacy of Ketorolac and Lidocaine Inferior Alveolar Nerve Blocks in Patients With With Symptomatic Irreversible Pulpitis a Prospective Double Blind Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-01
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:
IANB
Brief Summary:
The aim of this study is to determine whether inferior alveolar nerve block of ketorolac and lidocaine would improve the success rate in teeth with symptomatic irreversible Pulpitis
Design In this randomized double-blind clinical trial sixty healthy adult volunteers with including criteria have been randomly divided into two groups n30 Following the 5 minutes of the first IANB using 18 ml 2 lidocaine 2 containing 1100000 the patients of case group have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mgml The patients of the control group received a sham injection After achieving the lip numbness access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test Any pain during caries and dentin removal access cavity preparation and root canal preparation have been recorded using analog visual scale HP-VAS The success was considered as none or mild pain during treatment The data have been analyzed using Mann-U-Whitney test
Intervention main outcome measures Pain during caries and dentin removal access cavity preparation and root canal preparation using VAS
Design In this randomized double-blind clinical trial sixty healthy adult volunteers with including criteria have been randomly divided into two groups n30 Following the 5 minutes of the first IANB using 18 ml 2 lidocaine 2 containing 1100000 the patients of case group have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mgml The patients of the control group received a sham injection After achieving the lip numbness access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test Any pain during caries and dentin removal access cavity preparation and root canal preparation have been recorded using analog visual scale HP-VAS The success was considered as none or mild pain during treatment The data have been analyzed using Mann-U-Whitney test
Intervention main outcome measures Pain during caries and dentin removal access cavity preparation and root canal preparation using VAS
Detailed Description:
The aim of this study is to determine whether inferior alveolar nerve block of ketorolac and lidocaine would improve the success rate in teeth with symptomatic irreversible Pulpitis Design In this randomized double-blind clinical trial sixty healthy adult volunteers with including criteria have been randomly divided into two groups n30 All patients have been received standard inferior alveolar nerve block injection that used 18 ml 2 lidocaine 2 containing 1100000 after negative aspiration After 5 minutes 30 patients have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mgml the other 30 patients received a sham injection After achieving the lip numbness the pulp anesthesia has been evaluated after 5 minutes by using electric pulp tester Pakell Inc Edgewood NY Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test Any pain during caries and dentin removal access cavity preparation and root canal preparation have been recorded using analog visual scale HP-VAS The success was considered as none or mild pain during treatment The data have been analyzed using Mann-U-Whitney testParticipants including major eligibility criteria all patients with symptomatic irreversible pulpitis HP VAS 54 of a mandibular molar tooth without systemic diseases nonsmoking without any medicine consumption or analgesic and sedation Intervention Main outcome measures Pain during caries and dentin removal access cavity preparation and root canal preparation using VAS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None