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

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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.
We found this trial at
2
sites
Milwaukie, Oregon 97222
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Milwaukie, OR
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Portland, Oregon 97221
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Portland, OR
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