Clinical trial NCT02918045: Dental Extractions in Patients Under Dual Antiplatelet Therapy
Official title: Dental Extractions in Patients Under Dual Antiplatelet Therapy: Comparison of Two Local Hemostatic Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Coagulation Disorders
Keywords: Tooth Extraction
Surgical Hemostasis
Platelet Aggregation Inhibitors
Chitosan
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind, Randomized, Split-mouth
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Primary bleeding
timeFrame: Intraoperative
Secondary outcomes:
measure: Point-of-care platelet function test
timeFrame: Day before dental extraction
Other outcomes:
measure: Secondary bleeding (T1)
timeFrame: 10-15 hours after dental extraction
measure: Secondary bleeding (T2)
timeFrame: 45-50 hours after dental extraction
measure: Intra patient healing comparison
timeFrame: 1 week post surgery
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração (InCor HCFMUSP)
Study officials:
affiliation: University of Sao Paulo
name: Itamara LI Neves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: José C Nicolau, PhD
role: STUDY_DIRECTOR
References: