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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
Sponsor:
Information provided by (Responsible Party):
Bruno Guardieiro, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Coagulation Disorders Device: HemCon Dental Dressing Device: Oxidized Cellulose Gauze Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring two or more dental extraction procedures.
  • Patients must be under dual antiplatelet therapy of any kind.
  • Patients must be 18 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.
  • Extraction sites do not require primary closure of suturing.
  • Willingness and ability to provide informed consent

Exclusion Criteria:

  • Patients who are currently undertaking other anticoagulant medications (e.g., aspirin, coumadin, heparin) or have discontinued their anticoagulant medications.
  • History of heart attack in less than 1 week.
  • Patients with seafood allergy.
  • Unable of unwilling to provide informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Bruno Guardieiro, DDS +55 11 982797899 brunoguardieiro@gmail.com

Locations
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Brazil
Instituto do Coração (InCor HCFMUSP) Recruiting
São Paulo, Brazil
Contact: Bruno Guardieiro, DDS       brunoguardieiro@gmail.com   
Contact: Itamara LI Neves, PhD       itamara.neves@incor.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Itamara LI Neves, PhD University of Sao Paulo
Study Director: José C Nicolau, PhD University of Sao Paulo

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Responsible Party: Bruno Guardieiro, PhD degree student, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02918045     History of Changes
Other Study ID Numbers: DUALex
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bruno Guardieiro, University of Sao Paulo General Hospital:
Tooth Extraction
Surgical Hemostasis
Platelet Aggregation Inhibitors
Chitosan

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hemostatics
Chitosan
Cellulose, Oxidized
Coagulants
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents