Analgesic Effects of Peripherally Administered Opioids in a Clinical Model of Chronic Inflammation
Data Collection
Stomatognathic Diseases+5
+ Neurologic Manifestations
+ Pathologic Processes
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.275 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps