Healthy Clinical Trial
Official title:
Analgesic Effects of Peripherally Administered Opioids in a Clinical Model of Chronic Inflammation
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 patient's 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 patient's 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.
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 1:100,000 epinephrine when used on inflamed mandibular molar teeth. Delivering lidocaine 2% with 1:100,000 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. ;
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |