Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01496846
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2011-12-09
Brief Title:
Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Articaine Versus Lidocaine Supplemental Infiltration Efficacy in Irreversible Pulpitis Mandibular Molars After Failed Inferior Alveolar Nerve Block
Status:
COMPLETED
Status Verified Date:
2017-09
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:
ARTIC
Brief Summary:
The purpose of this trial is to study the ability of a frequently used dental anesthetic articaine to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw inferior alveolar nerve block IANB If this technique fails a commonly used supplemental SUP technique with one of two possible dental anesthetics lidocaine or articaine will be given to evaluate the successfailure of complete numbness between the two anesthetics
Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe
The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits
This study consisted of two periods of patient enrollment treatment and data collection Part I 101 subjects Part II 100 subjects
Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe
The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits
This study consisted of two periods of patient enrollment treatment and data collection Part I 101 subjects Part II 100 subjects
Detailed Description:
The goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars either by IANB administration of 4 articaine with 1100000 epinephrine NDA 022466 or in case the IANB appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine
The proposed randomized controlled trial RCT aims to answer the following questions
1 What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration
2 Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB
3 Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine
This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size giving a total sample size of approximately 200 patients
The proposed randomized controlled trial RCT aims to answer the following questions
1 What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration
2 Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB
3 Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine
This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size giving a total sample size of approximately 200 patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00049692 | OTHER | None | None |
| HUM00088384 | OTHER | U-Michigan | None |