Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
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.
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.
Study Design
Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Tooth Extractions
Intervention
HemCon Dental Dressing, Gauze with pressure
Location
Rodney Nichols, DMD
Milwaukie
Oregon
United States
97222
Status
Terminated
Source
HemCon Medical Technologies, Inc
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00707564
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Air Abrasion, Dental
A technique using a pneumatic, high-pressure stream of aluminum oxide to remove DENTAL ENAMEL; DENTIN; and restorative materials from teeth. In contrast to using DENTAL HIGH-SPEED EQUIPMENT, this method usually requires no dental anesthesia (ANESTHESIA, DENTAL) and reduces risks of tooth chipping and microfracturing. It is used primarily for routine DENTAL CAVITY PREPARATION.
Tooth, Nonvital
A tooth from which the dental pulp has been removed or is necrotic. (Boucher, Clinical Dental Terminology, 4th ed)
Tooth Germ
The collective tissues from which an entire tooth is formed, including the DENTAL SAC; ENAMEL ORGAN; and DENTAL PAPILLA. (From Jablonski, Dictionary of Dentistry, 1992)
Dental Care For Children
The giving of attention to the special dental needs of children, including the prevention of tooth diseases and instruction in dental hygiene and dental health. The dental care may include the services provided by dental specialists.
Dental Prosthesis
An artificial replacement for one or more natural teeth or part of a tooth, or associated structures, ranging from a portion of a tooth to a complete denture. The dental prosthesis is used for cosmetic or functional reasons, or both. DENTURES and specific types of dentures are also available. (From Boucher's Clinical Dental Terminology, 4th ed, p244 & Jablonski, Dictionary of Dentistry, 1992, p643)
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