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Completed

NCT Number: NCT04846114

Dental Implants in Patients Under Oral Anticoagulant Therapy

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association

Buenos Aires, 1125, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental implant surgery

Procedure

Primary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Jorge Ernesto Aguilar

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 15, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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