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The purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions.
Postoperative hemostasis is a fundamental patient management issue in the oral and maxillofacial surgery setting. The risk of excessive bleeding prompts physicians to stop multiple antiplatelet agents before minor surgery, which puts coronary stenting patients at risk for adverse thrombotic events. Adequate hemostasis must be achieved in order to make oral surgeries possible for these patients without discontinuation of the antiplatelet regimen. The HemCon Dental Dressing (HemCon Medical Technologies, Inc, Beaverton, OR) is a novel chitosan-based hemostatic agent which may greatly improve upon the efficacy of wound healing and hemostasis both in extent and time for minor oral surgeries. Dental extractions will be performed in patients under dual antiplatelet therapy without altering their medication regimen. All patients will require to have two or more surgical sites so they will have internal surgical control sites. Cutaneous bleeding time and platelet aggregation tests will be obtained prior to extractions. The primary hemostasis will be evaluated by measuring the intraoral bleeding time after each extraction and further bleeding and healing outcomes will be ascertain by phone questionaires and clinical evaluations. The aim of this study is to evaluate the effectiveness of HemCon Dental Dressing in controlling post extraction bleeding and to ascertain its role in healing of extraction wounds compared to a standard haemostasis method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemcon Dental Dressing | Experimental | The HemCon® Bandage is an FDA-cleared chitosan-based flat bandage that controls severe arterial bleeding from traumatic injuries. In comparison to traditional bandages, the HemCon® Bandage provides superior control of bleeding, wound site adhesiveness, multiple injury site usage, biocompatibility and provides a barrier to infective agents. |
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| Oxidized Cellulose Gauze | Active Comparator | A common hemostatic measure after dental extractions involves the placement of an absorbable oxidized cellulose gauze Surgicel (Ethicon, Inc, San Angelo, TX) into the extraction socket. This treatment was chosen as the study control to compare the HemCon Dental Dressing to the standard local hemostatic care for oral surgery subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HemCon Dental Dressing | Device | The Hemcon Dental Dressing is an oral wound dressing made of chitosan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary bleeding | Primary bleeding will be evaluated by recording the intra-oral bleeding time. The extraction site will be observed for 2 min without gauze in place. At the end of 2 min, gauze is placed over the extraction site to remove blood extending beyond the tooth socket. After blotting the extraction site, any bleeding that extends beyond the crest of the socket will be recorded as a positive test result (i.e., onto surrounding gingival tissues) during an observation period of 1 min. This same procedure was performed at 5, 8, 11, 14, and 20 min after the extraction. Intra-oral bleeding time is defined as the length of time for bleeding to cease to extend beyond the tooth socket. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Point-of-care platelet function test | Blood platelet function plays a pivotal role in hemostasis during surgery and following traumatic injuries. The ability to assess platelet function before the intervention is desirable in patients undergoing dental extraction procedures. A point-of-care platelet function test (Multiplate - Roche Diagnostics, Mannheim, Germany) will be performed the morning before dental extraction to assess platelet function inhibition due to dual antiplatelet therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary bleeding (T1) | Secondary bleeding (T1) will be evaluated by telephone with standardized questionnaire including the following: whether bleeding occurred after the individual left the dental clinic (y/n); whether gauze was needed to be placed due to bleeding (y/n); and whether an emergency service or dental clinic was visited due to bleeding (y/n). | 10-15 hours after dental extraction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itamara LI Neves, PhD | University of Sao Paulo | Principal Investigator |
| José C Nicolau, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração (InCor HCFMUSP) | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Single-blind, Randomized, Split-mouth
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The participant (patient) does not know which site received the study local hemostatic or the control local hemostatic.It is not possible for the surgeon to be blinded in this case.
| Oxidized Cellulose Gauze | Device | A common hemostatic measure after dental extractions placed into the extraction socket. |
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| Day before dental extraction |
| Secondary bleeding (T2) | Secondary bleeding (T2) will be evaluated by telephone with standardized questionnaire including the following: whether bleeding occurred after the individual left the dental clinic (y/n); whether gauze was needed to be placed due to bleeding (y/n); and whether an emergency service or dental clinic was visited due to bleeding (y/n). | 45-50 hours after dental extraction |
| Intra patient healing comparison | Healing will be compared between the study and control sites and assessed on a scale of 1-3 with 1 representing the healing of the study site being significantly worse than the control; 2 representing the healing of the study site being the same as the control, and 3 meaning the healing of the study site was significantly better than the control. | 1 week post surgery |