Dental Implants in Patients Under Oral Anticoagulant Therapy

October 9, 2022 updated by: Jorge Ernesto Aguilar

Efficacy of Local Hemostatic Management in Implant Surgery in Anticoagulated Patients on Warfarin: a Randomized Clinical Study

This study evaluated the outcomes in the post-operative recovery following dental implant surgery in patients who continued on oral anticoagulated therapy (OAT) with warfarin. The primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery and presence of intraoral/extraoral hematomas in skin and mucosa oral.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was compare: 1) the frequency of immediate and short term postoperative bleeding using tranexamic acid (TXAg), bismuth subgallate (BSg) or dry gauze (DGg) as local hemostatic 2) explore the relation between bleeding and the occurrence of hematomas, with length of incision, duration of surgery, and alveolar ridge recontouring. 80 surgical procedures performed in a total of 71 patients (20 surgical procedures in 18 patients not on OAT and 60 surgical procedures performed in 53 patients on OAT) that were assigned to one of four groups, so that each group included 20 procedures. The control group (Cg) comprised 20 procedures performed in patients not on OAT. The 60 procedures to be performed in patients on OAT were randomly to one of the three following experimental groups: 1) TXAg group, OAT plus TXA as local hemostatic agent; 2) BSg group, OAT plus BS as local hemostatic agent; 3) DGg group, OAT plus compression with dry gauze as local hemostatic agent. Outcomes variables were:

Intraoperative variables: length of incision expressed (Li) alveolar ridge recontouring (Arr), total duration of surgery (Ds), surgical quadrant and implant location.

Postoperative variables: immediate postoperative bleeding (within the first 30 minutes after surgery), short-term bleeding: within the first 5 days post-surgery, determined according to the index described by Bacci, presence of intraoral/extraoral hematomas in skin or mucosa. Descriptive statistical, analysis of variance and regression logistic analysis was performed. Statistical significance was set at a value of p<0.05.

Study Type

Interventional

Enrollment (Actual)

71

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

  • Argentina
      • Buenos Aires, Argentina, 1125
        • Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects:

  • Systemically healthy.
  • Healthy periodontal tissues or well-controlled periodontal health.
  • In need of a maximum of two dental implants per hemiarcade,
  • Showing ≥8mm bone height and ≥6 horizontal bone width.
  • Needing a maximum of two surgical procedures.
  • Who had written consent from the referring service to undergo the surgical procedure.

Exclusion Criteria:

Subjects:

  • Requiring implant placement immediately after extraction.
  • Systemic disease contraindicating implant surgery.
  • Mental disability preventing them from complying with the protocol.
  • Hematological, metabolic, autoimmune or bone diseases.
  • Hepatic alterations or receiving medication affecting liver function.
  • Receiving corticoid therapy, chemotherapy, or anticoagulant therapy within 10 days prior to the surgery.
  • Taking antibiotics that interact with oral anticoagulants.
  • Requiring vertical or periosteal incisions.
  • Requiring bone regeneration strategy.

When treatment involved placing an implant in more than one hemiarcade, the corresponding surgeries were scheduled 30 days apart.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (Cg)

The control group (Cg) comprised 20 procedures performed in patients not on OAT.

Buccal and palatal-lingual flaps were repositioned and sutured with simple stitches using 5/0 monofilament nylon yarn, and a dry gauze was applied for 30 minutes.
Procedure: Dental implant surgery
Experimental: Tranexamic acid group (TXAg)
TXAg group comprised 20 procedures performed in patients OAT. Buccal and palatal-lingual flaps were repositioned and sutured as in the Cg plus compression on the wound for 30 minutes using a gauze soaked in the contents of a 500mg ampoule of TXA, after which a new gauze soaked in the contents of a 500mg ampoule of TXA was applied for two hours.
Procedure: Dental implant surgery
Experimental: Bismuth subgallate group (BSg)
BSg group comprised 20 procedures performed in patients OAT. At the moment of surgery, the contents of an anestube (1.8 ml) were mixed with a sufficient amount of BS powder to obtain a paste similar in consistency to tooth-paste (29). A thin layer of the paste was applied on the bone ridge, and buccal and palatal-lingual flaps were then repositioned and sutured as in the Cg. compression on the wound with a dry gauze for 30 minutes, after which a new dry gauze was placed for another two hours.
Procedure: Dental implant surgery
Experimental: Dry gauze group (DGg)
DGg group comprised 20 procedures performed in patients OAT. Buccal and palatal-lingual flaps were repositioned and sutured as in the Cg plus compression on the wound with a dry gauze for 30 minutes, after which a new dry gauze was placed for another two hours.
Procedure: Dental implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of immediate postoperative bleeding events
Time Frame: Within the first 30 minutes after surgery
0: no bleeding; -1: mild bleeding defined as minor oozing from the wound incision controlled with compressive gauze only -2: moderate bleeding associated with the presence of large clots continuously disrupting the surgical area and requiring additional hemostatic measures; -3: severe bleeding requiring further medical control of coagulation
Within the first 30 minutes after surgery
Number of short-term bleeding events
Time Frame: Within the first 5 days post-surgery
0: no bleeding; -1: mild bleeding defined as minor oozing from the wound incision controlled with compressive gauze only -2: moderate bleeding associated with the presence of large clots continuously disrupting the surgical area and requiring additional hemostatic measures; -3: severe bleeding requiring further medical control of coagulation
Within the first 5 days post-surgery
Number of presence of intraoral hematomas events
Time Frame: On day 7 post-surgery
changes in mucosa color and edema (recorded as a dichotomous variable- yes/no).
On day 7 post-surgery
Number of presence of extraoral hematomas events
Time Frame: On day 7 post-surgery
changes in skin color and edema (recorded as a dichotomous variable- yes/no).
On day 7 post-surgery

Collaborators and Investigators

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

Sponsor

Jorge Ernesto Aguilar

Investigators

  • Study Director: Jorge Aguilar, Chair Prof, Universidad del Salvador
  • Principal Investigator: Mariano Vassallo, Assoc Prof, Universidad del Salvador
  • Principal Investigator: Jose Zamberlin, Assoc Prof, Universidad del Salvador
  • Principal Investigator: Marina Diaz Roig, Assist Prof, Universidad del Salvador
  • Study Chair: Ricardo Macchi, Chair Prof, University of Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 11, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VRID 1500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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