Tooth Extractions
Conditions
Keywords
hemostasis, tooth extractions
Brief 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.
Detailed 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.
Interventions
DEVICEHemCon Dental Dressing
The HemCon Dental Dressing is an oral wound dressing made of chitosan
DEVICEGauze with pressure
Gauze with pressure
Sponsors
HemCon Medical Technologies, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care * Patients requiring a minimum of 2 tooth extraction procedures. * Index pairing must reflect anatomically similar extraction locations * 14 years of age or older * Available for a minimum of one post operative evaluation approximately 7 days post surgery * Extraction sites do not require primary closure or suturing * Willingness and ability to provide informed consent/ assent
Exclusion criteria
* Scheduled to undergo a procedure other than tooth extractions * In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use * Scheduled to undergo 2 extractions, anatomically dissimilar * Extraction procedures are expected to require primary closure or suture * Unwilling or unable to provide informed consent/ assent * Patients undergoing bisphosphonate therapy * Patients not under current treatment with an oral anticoagulant medication * Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to hemostasis | minutes after application |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of post surgical sequela | 1 week post surgery |
Countries
United States
Outcome results
None listed