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Sponsored by: |
HemCon Medical Technologies, Inc |
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Information provided by: | HemCon Medical Technologies, Inc |
ClinicalTrials.gov Identifier: | NCT00707564 |
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.
Condition | Intervention |
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Tooth Extractions |
Device: Hemcon Dental Dressing Device: Gauze with pressure |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the Hemcon Dental Dressing in a Population Treated With Anticoagulant Medications |
Estimated Enrollment: | 38 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Hemcon Dental Dressing
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Device: Hemcon Dental Dressing
The Hemcon Dental Dressing is an oral wound dressing made of chitosan
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2: Active Comparator
Gauze with pressure
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Device: Gauze with pressure
Gauze with pressure
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Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon Wilson | 503 292 8824 | Sharon@drjaypmalmquist.com |
United States, Oregon | |
Jay P. Malmquist, DMD | Recruiting |
Portland, Oregon, United States, 97221 | |
Sub-Investigator: Stephen Clemens, DMD | |
Rodney Nichols, DMD | Recruiting |
Milwaukie, Oregon, United States, 97222 | |
Contact: Rodney Nichols, DMD 503-654-3530 | |
Principal Investigator: Rodney Nichols, DMD |
Principal Investigator: | Jay Malmquist, DMD | Jay P. Malmquist, DMD, PC |
Responsible Party: | Hemcon Medical Technologies, Inc ( Leslie North, Vice President Clinical Trials ) |
Study ID Numbers: | 2007-I-D-2 |
Study First Received: | June 27, 2008 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00707564 |
Health Authority: | United States: Food and Drug Administration |
hemostasis, tooth extractions |
Chitosan |