Dental Extractions in Patients Under Dual Antiplatelet Therapy (DUALex)

September 6, 2019 updated by: Bruno Guardieiro, University of Sao Paulo General Hospital

Dental Extractions in Patients Under Dual Antiplatelet Therapy: Comparison of Two Local Hemostatic Techniques

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil
        • Instituto do Coração (InCor HCFMUSP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.
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.
A common hemostatic measure after dental extractions placed into the extraction socket.
Other Names:
  • Surgicel (Ethicon, Inc, San Angelo, TX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day before dental extraction

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10-15 hours after dental extraction
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).
45-50 hours after dental extraction
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.
1 week post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Itamara LI Neves, PhD, University of Sao Paulo
  • Study Director: José C Nicolau, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2017

Primary Completion (ACTUAL)

July 16, 2019

Study Completion (ACTUAL)

July 23, 2019

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (ESTIMATE)

September 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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