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A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
This study is currently recruiting participants.
Verified by HemCon Medical Technologies, Inc, July 2008
Sponsored by: HemCon Medical Technologies, Inc
Information provided by: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT00707486
  Purpose

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


Condition Intervention
Tooth Extractions
Device: Hemcon Dental Dressing
Device: Gauze with Pressure

Drug Information available for: Chitosan
U.S. FDA Resources
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

Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:
  • Time to Hemostasis [ Time Frame: minutes after application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of post surgical sequellae [ Time Frame: 1 week post surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: June 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Hemcon Dental Dressing
Device: Hemcon Dental Dressing
The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
2: Active Comparator
Gauze with pressure
Device: Gauze with Pressure
Gauze with pressure

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707486

Contacts
Contact: Sharon Wilson (503) 292-8824 Sharon@drjaypmalmquist.com

Locations
United States, Oregon
Jay P. Malmquist, DMD Recruiting
Portland, Oregon, United States, 97221
Principal Investigator: Jay Malmquist, DMD            
Sub-Investigator: Stephen Clemens, DMD            
Rodney Nichols, DMD Recruiting
Milwaukie, Oregon, United States, 97222
Contact: Rodney Nichols, DMD     503-654-3530        
Sponsors and Collaborators
HemCon Medical Technologies, Inc
Investigators
Principal Investigator: Jay P Malmquist, DMD Jay P. Malmquist, DMD, PC
  More Information

Responsible Party: HemCon Medical Technologies, Inc. ( Leslie North, Vice President Clinical Trials )
Study ID Numbers: 2007-I-D-1
Study First Received: June 27, 2008
Last Updated: July 9, 2008
ClinicalTrials.gov Identifier: NCT00707486  
Health Authority: United States: Food and Drug Administration

Keywords provided by HemCon Medical Technologies, Inc:
Hemostasis, tooth extractions, third molar

Study placed in the following topic categories:
Chitosan

ClinicalTrials.gov processed this record on January 16, 2009