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
Men and women whose mandibular molars are either: intact, caries-free, and have no signs
or symptoms of pulpal disease or carious, symptomatic (to hot/cold and percussion), but
have no evidence of pulpal necrosis or infection. At least one intact caries-free
contralateral mandibular molar must be present.
Individuals should be healthy and over the age of 16.
No history of stomach ulcers, asthma, lung problems, or allergy to lidocaine, fentanyl or
any of the standard or test medications.
No body weight which is 30% greater or less than standard height-weight tables.
No pregnant or lactating females. Also, no females who are sexually active and will not
submit to a pregnancy test.
No history of taking any analgesics or antihistamines for 24 hr period prior to study.
No patients taking steroids or other anti-inflammatory drugs.
Willing to accept root canal treatment without parenteral sedation.
Willing to participate in data collection procedures.
No clinically significant medical history or signs of debilitation including patients with
heart, respiratory, renal, or liver dysfunction.
No history of personality disorder, alcohol abuse or drug abuse.
No chronic use of drugs which would confound assessment including barbituates,
anticonvulsants, tranquilizers, antiarrythmics, beta blockers, and antidepressants.
No patients whose mandibular molars are heavily restored (i.e., crowns, large fillings).
No hypersensitivity to drugs used (epinephrine, lidocaine, fentanyl).