Dental Implants in Patients Under Oral Anticoagulant Therapy

Sponsor

Jorge Ernesto Aguilar (Other)

Overall Status

Completed

CT.gov ID

NCT04846114

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Anticoagulant Therapy	Procedure: Dental implant surgery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Single (Participant)

Masking Description:

The participants on OAT allocated to one of the three different local hemostatic strategies, were not informed wich agent was used. Time of compression was equal in all groups.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of immediate postoperative bleeding events [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
Number of short-term bleeding events [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
Number of presence of intraoral hematomas events [On day 7 post-surgery]
changes in mucosa color and edema (recorded as a dichotomous variable- yes/no).
Number of presence of extraoral hematomas events [On day 7 post-surgery]
changes in skin color and edema (recorded as a dichotomous variable- yes/no).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.