Clinical trial NCT04846114: Dental Implants in Patients Under Oral Anticoagulant Therapy
Official title: Efficacy of Local Hemostatic Management in Implant Surgery in Anticoagulated Patients on Warfarin: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Anticoagulant Therapy
Keywords: Dental Implants
Anticoagulant Therapy
Warfarin
Tranexamic Acid
Bismuth subgallate
Lead sponsor: Universidad del Salvador, Argentina
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 80 surgical procedures (pr) in 71 patients (18 not OAT/53 on OAT) were assigned to one of four groups: control group (Cg n=20 pr not OAT) and 3 experimental groups of patients on OAT with local hemostatic management were randomized: tranexamic acid group (TXAg n=20 pr), bismuth subgallate group (BSg n=20 pr) and dry gauze group (DGg n=20 pr).
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of immediate postoperative bleeding events
timeFrame: Within the first 30 minutes after surgery
measure: Number of short-term bleeding events
timeFrame: Within the first 5 days post-surgery
measure: Number of presence of intraoral hematomas events
timeFrame: On day 7 post-surgery
measure: Number of presence of extraoral hematomas events
timeFrame: On day 7 post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association
Study officials:
affiliation: Universidad del Salvador
name: Jorge Aguilar, Chair Prof
role: STUDY_DIRECTOR
affiliation: Universidad del Salvador
name: Mariano Vassallo, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Salvador
name: Jose Zamberlin, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Salvador
name: Marina Diaz Roig, Assist Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Buenos Aires
name: Ricardo Macchi, Chair Prof
role: STUDY_CHAIR
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