Dental Implants in Patients Under Oral Anticoagulant Therapy

NCT ID: NCT04846114

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-06-30

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.

Conditions

Oral Anticoagulant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dental implant surgery

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Dental implant surgery

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Dental implant surgery

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Dental implant surgery

Intervention Type: PROCEDURE

Interventions

Dental implant surgery

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jorge Ernesto Aguilar

OTHER

Sponsor Role: lead

Responsible Party

Jorge Ernesto Aguilar

Director and Professor, Oral Implantology Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jorge Aguilar, Chair Prof

Role: STUDY_DIRECTOR

Universidad del Salvador

Mariano Vassallo, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Universidad del Salvador

Jose Zamberlin, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Universidad del Salvador

Marina Diaz Roig, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Universidad del Salvador

Ricardo Macchi, Chair Prof

Role: STUDY_CHAIR

University of Buenos Aires

Locations

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

Buenos Aires, , Argentina

Countries

Argentina

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Other Identifiers

VRID 1500

Identifier Type: -

Identifier Source: org_study_id