Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707564
Recruitment Status : Withdrawn (unable to enroll patient population)
First Posted : July 1, 2008
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Tooth Extractions Device: HemCon Dental Dressing Device: Gauze with pressure Not Applicable

Detailed Description:
As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigate the safety and efficacy of hemostasis of the dressing for use in dental surgical procedures that do not require primary closure (suturing) such as tooth extractions. This protocol will specifically research the safety and efficacy of hemostasis within a population of subjects taking anticoagulant medications.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
Study Start Date : July 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: 1
HemCon Dental Dressing
Device: HemCon Dental Dressing
The HemCon Dental Dressing is an oral wound dressing made of chitosan
Other Name: HemCon Dental Dressing.

Active Comparator: 2
Gauze with pressure
Device: Gauze with pressure
Gauze with pressure
Other Name: Generic brand gauze with pressure.

Primary Outcome Measures :
  1. Time to hemostasis [ Time Frame: minutes after application ]

Secondary Outcome Measures :
  1. Incidence of post surgical sequela [ Time Frame: 1 week post surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
  • Patients requiring a minimum of 2 tooth extraction procedures.
  • Index pairing must reflect anatomically similar extraction locations
  • 14 years of age or older
  • Available for a minimum of one post operative evaluation approximately 7 days post surgery
  • Extraction sites do not require primary closure or suturing
  • Willingness and ability to provide informed consent/ assent

Exclusion Criteria:

  • Scheduled to undergo a procedure other than tooth extractions
  • In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
  • Scheduled to undergo 2 extractions, anatomically dissimilar
  • Extraction procedures are expected to require primary closure or suture
  • Unwilling or unable to provide informed consent/ assent
  • Patients undergoing bisphosphonate therapy
  • Patients not under current treatment with an oral anticoagulant medication
  • Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00707564

United States, Oregon
Rodney Nichols, DMD
Milwaukie, Oregon, United States, 97222
Jay P. Malmquist, DMD
Portland, Oregon, United States, 97221
Sponsors and Collaborators
HemCon Medical Technologies, Inc
Principal Investigator: Jay Malmquist, DMD Jay P. Malmquist, DMD, PC

Responsible Party: HemCon Medical Technologies, Inc Identifier: NCT00707564     History of Changes
Other Study ID Numbers: 2007-I-D-2
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by HemCon Medical Technologies, Inc:
tooth extractions

Additional relevant MeSH terms: