Status:
WITHDRAWN
Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
Lead Sponsor:
HemCon Medical Technologies, Inc
Conditions:
Tooth Extractions
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications.
Detailed Description
As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigat...
Eligibility Criteria
Inclusion
- Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
- Patients requiring a minimum of 2 tooth extraction procedures.
- Index pairing must reflect anatomically similar extraction locations
- 14 years of age or older
- Available for a minimum of one post operative evaluation approximately 7 days post surgery
- Extraction sites do not require primary closure or suturing
- Willingness and ability to provide informed consent/ assent
Exclusion
- Scheduled to undergo a procedure other than tooth extractions
- In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
- Scheduled to undergo 2 extractions, anatomically dissimilar
- Extraction procedures are expected to require primary closure or suture
- Unwilling or unable to provide informed consent/ assent
- Patients undergoing bisphosphonate therapy
- Patients not under current treatment with an oral anticoagulant medication
- Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00707564
Start Date
July 1 2008
End Date
January 1 2009
Last Update
September 24 2012
Active Locations (2)
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1
Rodney Nichols, DMD
Milwaukie, Oregon, United States, 97222
2
Jay P. Malmquist, DMD
Portland, Oregon, United States, 97221