Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001952
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Using a Narcotic to Enhance the Numbing Effect of the Local Anesthetic Lidocaine on Inflamed Molar Teeth
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analgesic Effects of Peripherally Administered Opioids in a Clinical Model of Chronic Inflammation
Status:
COMPLETED
Status Verified Date:
2002-12
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 effectiveness of local anesthetics is reduced if inflammation is present making it difficult to control pain during such procedures as root canals and wisdom teeth removal This set of studies will assess the effectiveness of the opioid synthetic narcotic fentanyl in enhancing the local anesthetic lidocaine delivered with epinephrine when used on inflamed molar teeth
In the first study a topical anesthetic patch or a placebo will be placed on the gum tissues next to four or five lower posterior teeth The patch will removed at either 5 10 or 15 minutes An electronic test that sends a light electronic impulse into the tooth lip sensitivity testing Is your lip numb and discomfort reports will be started immediately after removal of the patch and repeated every 5 minutes for 30 minutes An oral surgeon will then remove the patients wisdom teeth tooth
In the second and third studies a topical anesthetic will be placed on the gum tissue An electronic test that sends a light electronic impulse into the tooth lip sensitivity testing Is your lip numb and discomfort reports will be started and done several times throughout the test Then two small openings one on each side of the tooth will be drilled into the bony tissues surrounding the tooth A narcotic drug fentanyl or a placebo drug will be delivered through these openings allowing placement of the drug next to the nerves that are difficult to numb Lidocaine along with a small amount of epinephrine will be delivered An oral surgeon will then remove the patients wisdom teeth or tooth study 2 or do a root canal study 3
In the fourth study a topical anesthetic will be placed on the gum tissue Then two small openings one on each side of the tooth will be drilled into the bony tissues surrounding the tooth A narcotic drug fentanyl or a placebo drug will be delivered through these openings Lidocaine along with a small amount of epinephrine will be delivered at one of three rates 15 patients for each rate Blood pressure heart rate and breathing rate will be taken before the topical anesthetic patch is applied 2 minutes after and every 5 minutes for the next 45 minutes Blood samples will be taken 6 times over the course of 60 minutes When testing is complete an oral surgeon will remove the wisdom teeth tooth One month later blood samples will be taken using a different drug delivery method in order to compare results
In the first study a topical anesthetic patch or a placebo will be placed on the gum tissues next to four or five lower posterior teeth The patch will removed at either 5 10 or 15 minutes An electronic test that sends a light electronic impulse into the tooth lip sensitivity testing Is your lip numb and discomfort reports will be started immediately after removal of the patch and repeated every 5 minutes for 30 minutes An oral surgeon will then remove the patients wisdom teeth tooth
In the second and third studies a topical anesthetic will be placed on the gum tissue An electronic test that sends a light electronic impulse into the tooth lip sensitivity testing Is your lip numb and discomfort reports will be started and done several times throughout the test Then two small openings one on each side of the tooth will be drilled into the bony tissues surrounding the tooth A narcotic drug fentanyl or a placebo drug will be delivered through these openings allowing placement of the drug next to the nerves that are difficult to numb Lidocaine along with a small amount of epinephrine will be delivered An oral surgeon will then remove the patients wisdom teeth or tooth study 2 or do a root canal study 3
In the fourth study a topical anesthetic will be placed on the gum tissue Then two small openings one on each side of the tooth will be drilled into the bony tissues surrounding the tooth A narcotic drug fentanyl or a placebo drug will be delivered through these openings Lidocaine along with a small amount of epinephrine will be delivered at one of three rates 15 patients for each rate Blood pressure heart rate and breathing rate will be taken before the topical anesthetic patch is applied 2 minutes after and every 5 minutes for the next 45 minutes Blood samples will be taken 6 times over the course of 60 minutes When testing is complete an oral surgeon will remove the wisdom teeth tooth One month later blood samples will be taken using a different drug delivery method in order to compare results
Detailed Description:
The clinical efficacy of local anesthetics is reduced in the presence of inflammation sometimes limiting the ability to perform necessary therapeutic procedures Recent studies suggest however that opiate receptors are expressed in the dental pulp and oral mucosal tissues and increase in number under conditions of inflammation The proposed clinical study will assess the therapeutic effectiveness of the opioid fentanyl to enhance the profoundness of the local anesthetic lidocaine with 1100000 epinephrine when used on inflamed mandibular molar teeth Delivering lidocaine 2 with 1100000 epinephrine intraosseously immediately after delivering fentanyl intraosseously is predicted to increase the success rate of local anesthesia on the inflamed pulpal tissues of mandibular molars Three different strategies will be studied to assess fentanyl as an adjunct to local anesthesia The first study will assess the efficacy of individual drugs under normal conditions in patients whose mandibular molars have healthy pulpal tissues Pulpal anesthesia will be measured by an electronic pulp tester and drugs will be delivered intraosseously A second study will evaluate local anesthetic success using the same drugs and route of administration in patients whose mandibular molars have inflamed pulpal tissues Root canal treatment will test for the clinical effectiveness of local anesthesia A third study will assess systemic side effects using different rates of intraosseous drug delivery This series of studies may provide a rationale for the adjunctive administration of opioids in clinical conditions where inflammation limits the effectiveness of local anesthetics alone
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 |
|---|---|---|---|
| 00-D-0017 | None | None | None |