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

NCT00707486 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-01-09

Study results available
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Summary

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

Conditions

  • Tooth Extractions

Interventions

DEVICE

Hemcon Dental Dressing

The Hemcon Dental Dressing is an oral wound dressing made of chitosan.

DEVICE

Gauze with Pressure and/or Gelfoam

Common practice for oral surgery patients involves the use of sterile dressing over the extraction site. The subject will provide the pressure by biting down on the sterile gauze. As previously discussed, other practices involve the use of Gelfoam prior to application of sterile gauze.

Sponsors & Collaborators

  • HemCon Medical Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Jay P Malmquist, DMD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-01-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707486 on ClinicalTrials.gov