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Phase 3 N=72 Randomized Treatment

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

Tooth Extractions

Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Time to Hemostasis — 1.9; 9.8; 6.0 Minutes

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Hemcon Dental Dressing (Device); Gauze with Pressure and/or Gelfoam (Device)
Age
Pediatric, Adult, Older Adult · 14+ yrs
Sex
All
Sponsor
HemCon Medical Technologies, Inc
Primary completion
Jan 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Hemostasis
1.9; 9.8; 6.0
SECONDARY
Incidence of Post Surgical Sequelae
41.2; 55.6; 41.2; 38.2; 38.9; 44.1

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00707486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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