A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | June 2008 |
Contact: | Sharon Wilson |
Email: | Sharon@drjaypmalmquist.com |
Phone: | (503) 292-8824 |
The purpose of this study is to determine if the HemCon Dental Dressing is effective in
stopping bleeding during dental surgeries.
Inclusion Criteria:
- 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 Criteria:
- 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.
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