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WithdrawnNCT00707564Updated Sep 24, 2012

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

An interventional study of HemCon Dental Dressing and Gauze with pressure in Tooth Extractions, sponsored by HemCon Medical Technologies, Inc. Withdrawn at 2 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2012-09-24.

Sponsored by HemCon Medical Technologies, Inc · Not applicable, Interventional, and Treatment

Why this study was withdrawn
unable to enroll patient population
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
14 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Extractions

Keywords

  • hemostasis
  • tooth extractions
03

In context

Lead sponsor

HemCon Medical Technologies, Inc is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    HemCon Dental Dressing

    Device: HemCon Dental Dressing

  • Active comparator
    2

    Gauze with pressure

    Device: Gauze with pressure

Interventions

  • DeviceHemCon Dental Dressing

    The HemCon Dental Dressing is an oral wound dressing made of chitosan

    Also known as: HemCon Dental Dressing.

  • DeviceGauze with pressure

    Gauze with pressure

    Also known as: Generic brand gauze with pressure.

06

What researchers measure

Primary outcomes

  1. Time to hemostasis

    Time frame: minutes after application

Secondary outcomes

  1. Incidence of post surgical sequela

    Time frame: 1 week post surgery

07

Study locations

2 sites
  • Rodney Nichols, DMD
    Milwaukie, Oregon 97222, United States
  • Jay P. Malmquist, DMD
    Portland, Oregon 97221, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00707564
Lead sponsor
HemCon Medical Technologies, Inc
Responsible party
Sponsor
First posted
Jul 1, 2008
Start date
Jul 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Sep 24, 2012

Study contacts

Jay Malmquist, DMD
principal investigator · Jay P. Malmquist, DMD, PC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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