Dental Implants in Patients Under Oral Anticoagulant Therapy

Jorge Ernesto Aguilar

Status: Completed

Conditions: Oral Anticoagulant Therapy

Treatments: Procedure: Dental implant surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04846114

VRID 1500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 4 patient groups

Control group (Cg)

Active Comparator group

Description:

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.

Treatment:

Procedure: Dental implant surgery

Tranexamic acid group (TXAg)

Experimental group

Description:

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.

Treatment:

Procedure: Dental implant surgery

Bismuth subgallate group (BSg)

Experimental group

Description:

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.

Treatment:

Procedure: Dental implant surgery

Dry gauze group (DGg)

Experimental group

Description:

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.

Treatment:

Procedure: Dental implant surgery