HealthyNCT00001952
Using a Narcotic to Enhance the Numbing Effect of the Local Anesthetic Lidocaine on Inflamed Molar Teeth
An observational study of Healthy and Inflammation, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy, Inflammation, Mouth Disease
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Dec 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
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).
Read more
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.
Read the 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 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.
- Conditions
- Healthy, Inflammation, Mouth Disease, Pain
- Keywords
- Fentanyl, Intraosseous-Anesthesia, Endodontics, Denti Patch, Pain, Chronic Inflammation
- Medical subject headings
- Inflammation, Mouth Diseases, Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
- Study startNov 1999
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 275 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001952
- Sponsor's protocol ID
- 000017
- Other IDs
- 00-D-0017
- Status last verified
- Dec 2002
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Aberg G. Studies on the duration of local anesthesia: a possible mechanism for the prolonging effect of "vasoconstrictors" on the duration of infiltration anesthesia. Int J Oral Surg. 1980 Apr;9(2):144-7. doi: 10.1016/s0300-9785(80)80051-2.
PubMed 6773898Andreev N, Urban L, Dray A. Opioids suppress spontaneous activity of polymodal nociceptors in rat paw skin induced by ultraviolet irradiation. Neuroscience. 1994 Feb;58(4):793-8. doi: 10.1016/0306-4522(94)90456-1.
PubMed 8190256Dionne RA, Gordon SM, McCullagh LM, Phero JC. Assessing the need for anesthesia and sedation in the general population. J Am Dent Assoc. 1998 Feb;129(2):167-73. doi: 10.14219/jada.archive.1998.0173.
PubMed 9495047
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Peripherally Administered Opioids in a Clinical Model of Chronic Inflammation
- ClinicalTrials.gov ID
- NCT00001952
- Acronym / sponsor ID
- 000017
- Conditions
- Healthy, Inflammation, Mouth Disease, Pain
- Keywords
- Fentanyl, Intraosseous-Anesthesia, Endodontics, Denti Patch, Pain, Chronic Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Nov 1999
- Study completion
- Dec 2002
- First posted
- 19 Jan 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 6773898Aberg G. Studies on the duration of local anesthesia: a possible mechanism for the prolonging effect of "vasoconstrictors" on the duration of infiltration anesthesia. Int J Oral Surg. 1980 Apr;9(2):144-7. doi: 10.1016/s0300-9785(80)80051-2.
- Background: PubMed 8190256Andreev N, Urban L, Dray A. Opioids suppress spontaneous activity of polymodal nociceptors in rat paw skin induced by ultraviolet irradiation. Neuroscience. 1994 Feb;58(4):793-8. doi: 10.1016/0306-4522(94)90456-1.
- Background: PubMed 9495047Dionne RA, Gordon SM, McCullagh LM, Phero JC. Assessing the need for anesthesia and sedation in the general population. J Am Dent Assoc. 1998 Feb;129(2):167-73. doi: 10.14219/jada.archive.1998.0173.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Inflammation, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001952, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.