Dental Extractions in Patients Under Dual Antiplatelet Therapy (DUALex)
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|ClinicalTrials.gov Identifier: NCT02918045|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blood Coagulation Disorders||Device: HemCon Dental Dressing Device: Oxidized Cellulose Gauze||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Dental Extractions in Patients Under Dual Antiplatelet Therapy: Comparison of Two Local Hemostatic Techniques|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: Hemcon Dental Dressing
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.
Device: HemCon Dental Dressing
The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
Active Comparator: Oxidized Cellulose Gauze
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.
Device: Oxidized Cellulose Gauze
A common hemostatic measure after dental extractions placed into the extraction socket.
Other Name: Surgicel (Ethicon, Inc, San Angelo, TX)
- Primary bleeding [ Time Frame: Intraoperative ]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.
- Point-of-care platelet function test [ Time Frame: Day before dental extraction ]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.
- Secondary bleeding (T1) [ Time Frame: 10-15 hours after dental extraction ]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).
- Secondary bleeding (T2) [ Time Frame: 45-50 hours after dental extraction ]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).
- Intra patient healing comparison [ Time Frame: 1 week post surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918045
|Contact: Bruno Guardieiro, DDS||+55 11 firstname.lastname@example.org|
|Instituto do Coração (InCor HCFMUSP)||Recruiting|
|São Paulo, Brazil|
|Contact: Bruno Guardieiro, DDS email@example.com|
|Contact: Itamara LI Neves, PhD firstname.lastname@example.org|
|Principal Investigator:||Itamara LI Neves, PhD||University of Sao Paulo|
|Study Director:||José C Nicolau, PhD||University of Sao Paulo|