HealthyNCT00006175
Cyclooxygenase Levels Following Surgery to Remove Third Molars (Wisdom 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
This study will measure levels of an enzyme called cyclooxygenase in gum tissue following third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that normally follows tissue injury or surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy, Inflammation
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Oct 2005
- 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
Who may be able to join
- Subjects will be healthy volunteers between the ages 16-35 years presenting to the Clinical Center for removal of their third molars.
- The type of third molar will be characterized at the time of screening by oral exam and panoramic radiograph:
- Erupted tooth: Clinical crown is present in the mouth and is not covered by soft tissue.
- Soft tissue impaction: Clinical crown is not present in the mouth but the adjacent alveolar bone does not cover any portion of the crown in the radiograph.
- Partial bony impaction: Clinical crown is not present in the mouth and the alveolar bone covers some but not all of the crown in the radiograph.
- Full bony impaction: Clinical crown is not present in the mouth and the alveolar bone covers most or all of the crown in the radiograph.
- Patients will be eligible for inclusion in this study if the two mandibular molars are classified as partial or full bony impactions.
Who cannot join
- Patients who are pregnant or nursing.
- Presence of infection or inflammation [pericoronitis] at either extraction site.
- Patients who are taking any of the following drugs: anti-depressants, diuretics, aspirin on a near daily basis, coumadin or other blood thinners; or other drugs that might influence pain report or COX formation, e.g. steroids.
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: Cytokine Responses to Acute Inflammation in the Oral Surgery Model
This study will measure levels of an enzyme called cyclooxygenase in gum tissue following third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that normally follows tissue injury or surgery.
Healthy volunteers between 16 and 35 years of age who require removal of their third molars may be eligible for this study. Participants will receive an injection of a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein before surgery. Before the tooth is removed, a small tissue sample (biopsy) will be collected from the gum tissue covering one of the lower third molars to be extracted. After surgery, a second biopsy will be taken at some point between just after surgery to the time when pain from the extraction starts to develop. These tissue samples will be analyzed for cyclooxygenase levels.
Patients will stay in the clinic for up to 4 hours after surgery while the anesthetic wears off. During this time, they will complete pain questionnaires. If needed, patients may receive additional medicine for pain relief at any time during the surgery or the 4-hour observation period. They will also be given standard pain medication to take home at the end of the study.
Read the detailed description
Prostanoids are inflammatory mediators that have been implicated in all stages of acute and chronic inflammation. The inhibition of prostanoid synthesis by NSAIDs forms the basis of their therapeutic as well as side effects. NSAIDs directly inhibit cyclooxygenase [COX], which leads to reduction of prostaglandin synthesis but also to gastric erosions, inhibition of platelet aggregation and nephrotoxicity. The identification of the two isoforms of COX lead to the hypothesis that COX-2 is responsible for the production of prostaglandins following tissue injury, while COX-1 is involved in normal homeostasis. This hypothesis is primarily based on the results of animal studies and chronic inflammatory conditions such as arthritis. Recent results in the oral surgery model of acute inflammation suggest that COX-2 is present in the oral mucosa and may contribute to prostanoid production during acute inflammation rather than require induction in response to the injury. The proposed study aims to evaluate the time course of COX-1 and COX-2 in acute inflammation by evaluating levels of mRNA at baseline prior to surgery, at the completion of surgery, and at one, two and three hours following surgery.
- Conditions
- Healthy, Inflammation
- Keywords
- Cyclooxygenase, COX-1, COX-2, Prostanoids, P.C.R., Healthy Volunteer
- Medical subject headings
- Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2000 (estimated)
- Study startAug 2000
- Study completionOct 2005
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
- 160 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
- NCT00006175
- Sponsor's protocol ID
- 000190
- Other IDs
- 00-D-0190
- Status last verified
- Oct 2005
- First submitted
- 12 Aug 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Smith CJ, Zhang Y, Koboldt CM, Muhammad J, Zweifel BS, Shaffer A, Talley JJ, Masferrer JL, Seibert K, Isakson PC. Pharmacological analysis of cyclooxygenase-1 in inflammation. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):13313-8. doi: 10.1073/pnas.95.22.13313.
PubMed 9789085Pairet M, van Ryn J. Experimental models used to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by non-steroidal anti-inflammatory drugs. Inflamm Res. 1998 Oct;47 Suppl 2:S93-101. doi: 10.1007/s000110050289.
PubMed 9831330Morrison BW, Christensen S, Yuan W, Brown J, Amlani S, Seidenberg B. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial. Clin Ther. 1999 Jun;21(6):943-53. doi: 10.1016/S0149-2918(99)80016-2.
PubMed 10440619
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
- Cytokine Responses to Acute Inflammation in the Oral Surgery Model
- ClinicalTrials.gov ID
- NCT00006175
- Acronym / sponsor ID
- 000190
- Conditions
- Healthy, Inflammation
- Keywords
- Cyclooxygenase, COX-1, COX-2, Prostanoids, P.C.R., Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Oct 2005
- First posted
- 14 Aug 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.
This study will measure levels of an enzyme called cyclooxygenase in gum tissue following third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that normally follows tissue injury or surgery.
Healthy volunteers between 16 and 35 years of age who require removal of their third molars may be eligible for this study. Participants will receive an injection of a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein before surgery. Before the tooth is removed, a small tissue sample (biopsy) will be collected from the gum tissue covering one of the lower third molars to be extracted. After surgery, a second biopsy will be taken at some point between just after surgery to the time when pain from the extraction starts to develop. These tissue samples will be analyzed for cyclooxygenase levels.
Patients will stay in the clinic for up to 4 hours after surgery while the anesthetic wears off. During this time, they will complete pain questionnaires. If needed, patients may receive additional medicine for pain relief at any time during the surgery or the 4-hour observation period. They will also be given standard pain medication to take home at the end of the study.
Detailed description
Prostanoids are inflammatory mediators that have been implicated in all stages of acute and chronic inflammation. The inhibition of prostanoid synthesis by NSAIDs forms the basis of their therapeutic as well as side effects. NSAIDs directly inhibit cyclooxygenase [COX], which leads to reduction of prostaglandin synthesis but also to gastric erosions, inhibition of platelet aggregation and nephrotoxicity. The identification of the two isoforms of COX lead to the hypothesis that COX-2 is responsible for the production of prostaglandins following tissue injury, while COX-1 is involved in normal homeostasis. This hypothesis is primarily based on the results of animal studies and chronic inflammatory conditions such as arthritis. Recent results in the oral surgery model of acute inflammation suggest that COX-2 is present in the oral mucosa and may contribute to prostanoid production during acute inflammation rather than require induction in response to the injury. The proposed study aims to evaluate the time course of COX-1 and COX-2 in acute inflammation by evaluating levels of mRNA at baseline prior to surgery, at the completion of surgery, and at one, two and three hours following surgery.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects will be healthy volunteers between the ages 16-35 years presenting to the Clinical Center for removal of their third molars.
- The type of third molar will be characterized at the time of screening by oral exam and panoramic radiograph:
- Erupted tooth: Clinical crown is present in the mouth and is not covered by soft tissue.
- Soft tissue impaction: Clinical crown is not present in the mouth but the adjacent alveolar bone does not cover any portion of the crown in the radiograph.
- Partial bony impaction: Clinical crown is not present in the mouth and the alveolar bone covers some but not all of the crown in the radiograph.
Key exclusion criteria (3 listed)
- Patients who are pregnant or nursing.
- Presence of infection or inflammation [pericoronitis] at either extraction site.
- Patients who are taking any of the following drugs: anti-depressants, diuretics, aspirin on a near daily basis, coumadin or other blood thinners; or other drugs that might influence pain report or COX formation, e.g. steroids.
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 9789085Smith CJ, Zhang Y, Koboldt CM, Muhammad J, Zweifel BS, Shaffer A, Talley JJ, Masferrer JL, Seibert K, Isakson PC. Pharmacological analysis of cyclooxygenase-1 in inflammation. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):13313-8. doi: 10.1073/pnas.95.22.13313.
- Background: PubMed 9831330Pairet M, van Ryn J. Experimental models used to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by non-steroidal anti-inflammatory drugs. Inflamm Res. 1998 Oct;47 Suppl 2:S93-101. doi: 10.1007/s000110050289.
- Background: PubMed 10440619Morrison BW, Christensen S, Yuan W, Brown J, Amlani S, Seidenberg B. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial. Clin Ther. 1999 Jun;21(6):943-53. doi: 10.1016/S0149-2918(99)80016-2.
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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.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
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 NCT00006175, 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.