Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05227300
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2022-01-07
Brief Title:
Buffered vs Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Buffered vs Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis A Controlled Randomized Double-blind Study
Status:
COMPLETED
Status Verified Date:
2024-04
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 purpose of this study is to determine whether one type of anesthetic numbing medicine will work better at numbing the nerve in a tooth than using a different type of anesthetic A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics
Detailed Description:
40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups One group will receive a total of 3 cartridges of a standard unbuffered 2 lidocaine with 1100000 epinephrine via inferior alveolar nerve block IANB followed by supplemental buccal and lingual infiltrations while the other will receive the equivalent yet buffered formulation An electronic pulp tester EPT will be used to objectively determine baseline pulpal status of the affected tooth followed by 2-minute interval testing following the administration of all local anesthesia The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT80 readings and the endodontic treatment may begin Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None