Dental Extractions in Patients Under Dual Antiplatelet Therapy

NCT02918045 | Completed FDA Device

• 1 other identifier: DUALex
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation Disorders

Keywords

Tooth Extraction; Surgical Hemostasis; Platelet Aggregation Inhibitors; Chitosan

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Point-of-care platelet function test

  Day before dental extraction

Other Outcomes (3)

• Secondary bleeding (T1)

  10-15 hours after dental extraction

• Secondary bleeding (T2)

  45-50 hours after dental extraction

• Intra patient healing comparison

  1 week post surgery

Study Arms (2)

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.

Device: HemCon Dental Dressing

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.

Device: Oxidized Cellulose Gauze

Interventions

HemCon Dental Dressing DEVICE

The Hemcon Dental Dressing is an oral wound dressing made of chitosan.

Hemcon Dental Dressing

Oxidized Cellulose Gauze DEVICE

A common hemostatic measure after dental extractions placed into the extraction socket.

Also known as: Surgicel (Ethicon, Inc, San Angelo, TX)

Oxidized Cellulose Gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração (InCor HCFMUSP)

São Paulo, Brazil

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Itamara LI Neves, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• José C Nicolau, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD degree student

Model Details: Single-blind, Randomized, Split-mouth

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 28, 2016
• Study Start: April 11, 2017
• Primary Completion: July 16, 2019
• Study Completion: July 23, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

BR (1)