Status:
COMPLETED
A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Lead Sponsor:
HemCon Medical Technologies, Inc
Conditions:
Tooth Extractions
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries.
Detailed Description
The HemCon® Bandage has been successfully used to achieve hemostasis in patients with high systolic pressure, high blood volume wounds, and to promote hemostasis on a massive scale compared to the hem...
Eligibility Criteria
Inclusion
- Patients requiring 2 or 4 3rd molar tooth extraction procedures.
- Index pairing must reflect anatomically similar extraction locations, i.e., for 2 extractions both must be upper or both must be lower extractions.
- Patients must be 14 years of age or older
- Patients must be available for a minimum of one post operative evaluation to be scheduled at the time of the procedure approximately 7 days post surgery. Additional follow-up visits may be scheduled at the discretion of the surgeon based on the severity of particular patient cases or the patient's need for earlier follow-up.
- Extraction sites do not require primary closure or suturing
- Willingness and ability to provide informed consent/ assent for participation
- Patients with seafood allergies
- Patients who have discontinued the use of anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) for a minimum of 3 days prior to their planned surgical visit.
Exclusion
- Scheduled to undergo a surgical procedure other than 3rd molar tooth extractions
- Scheduled to undergo 2 extractions whereby one is an upper 3rd molar and the other is a lower 3rd molar. These will not reflect a proper index pairing for statistical calculations and data analysis based on anatomical similarities.
- Extraction procedures are expected to require primary closure or suturing of the HemCon® Dental Dressing within the oral wound.
- Unable or unwilling to provide informed consent/ assent for participation as a subject
- Patients who are currently taking anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) or have discontinued their anticoagulant medications less than 3 days prior to their surgical visit.
- Patients who are undergoing bisphosphonate therapy.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00707486
Start Date
June 1 2008
End Date
July 1 2009
Last Update
January 9 2013
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