A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Condition: Tooth Extractions
Intervention: Hemcon Dental Dressing; Gauze with Pressure and/or Gelfoam
Intervention description: The Hemcon Dental Dressing is an oral wound dressing made of chitosan.; 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.
Intervention MeSH terms: Gelatin Sponge, Absorbable
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: Hemostasis, tooth extractions, third molar

Summary:

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

Eligibility 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.