Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006175
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-08-12
Brief Title:
Cyclooxygenase Levels Following Surgery to Remove Third Molars Wisdom Teeth
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytokine Responses to Acute Inflammation in the Oral Surgery Model
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0190 | None | None | None |