A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing

Completed · Phase 3

Conditions studied: Tooth Extractions

In brief

The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries.

Key facts

Study ID

NCT00707486

Run by

HemCon Medical Technologies, Inc

People needed

72

Starts

2008-06-01

Expected to finish

2009-07-01

Last updated by the study team

2013-01-09

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rodney Nichols, DMD — Milwaukie, Oregon, United States
• Jay P. Malmquist, DMD — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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