Tranexamic acid as a mouthwash in

anticoagulant-treated patients undergoing

oral surgery
An alternative method to discontinuing anticoagulant therapy

G. Borea, DDS,a L. Montebugnoli, DDS,a P. Capuzzi, DDS,a C. Magelli, MD,b

Bologna, Italy

DEPARTMENT OF DENTISTRY AND INSTITUTE OF CARDIOLOGY, UNIVERSITY OF BOLOGNA

A double-blind randomized study was carried out to evaluate the clinical hemostatic effect of
tranexamic acid mouthwash after dental extraction in 30 patients who received anticoagulant
agents. Surgery was performed with a reduction in the level of anticoagulant therapy in the control
group and with no change in the level of anticoagulant therapy in the group who received the
tranexamic acid. After the extraction the surgical field was irrigated with a 5% solution of tranexamic
acid in the group of 15 patients whose anticoagulant treatment had not been discontinued and with
a placebo solution in the group of 15 patients for whom the anticoagulant therapy was reduced.
Patients were instructed to rinse their mouths with 10 ml of the assigned solution for 2 minutes four
times a day for 7 days. There was no significant difference between the two treatment groups in the
bleeding incidence after oral surgery. We conclude that the anticoagulant treatment does not need
to be withdrawn before oral surgery provided that local antifibrinolytic therapy is instituted.
(ORALSURC ORALh'tED ORALPATHOL19937529-31)

B efore oral surgery is performed in patients who

take oral anticoagulants, it is common practice to re-
duce or discontinue the anticoagulant medication to
lower the risk of bleeding.’ Before operating on such
patients, the surgeon must thus choose between
exposing them to the risk of thromboembolism or ex-
posing them to the risk of bleeding.2,3 It was recently
demonstrated that local antifibrinolytic therapy is ef-
fective in the prevention of bleeding after oral surgery
in patients taking oral anticoagulants.4 The aim of the
present research was to compare the incidence of
bleeding after oral surgery in patients who take oral
anticoagulants treated with tranexamic acid as a
mouthwash with those treated with the common
practice of discontinuing anticoagulant therapy.
MATERIAL AND METHODS
Thirty patients with cardiac valve prosthesis who
were being treated with an oral anticoagulant agent213
aDepartment of Dentistry.
bInstitute of Cardiology.
7/12/40613
and who were to undergo single dental extractions
were enrolled in the study. Prophylactic treatment
with antibiotics was begun preoperatively in all
patients (amoxicillin 3 gm 1 hour before treatment).
All patients received a local anesthetic with 3% me-
pivacaine, and all were treated by the same oral sur-
geon. Before dental extraction, the dental mobility
was defined as follows: (1) no mobility; (2) vestibular-
lingual mobility of less than 1 mm; (3) vestibular-lin-
gual mobility of more than 1 mm. Uncomplicated
single tooth extraction was performed without a mu-
cosal flap being raised, whereas complicated tooth
extraction was characterized by mucosal flap and
bone resection during surgery.
The study was carried out as a double-blind inves-
tigation with parallel groups that were used to com-
pare the hemostatic effect of 5% tranexamic acid used
as a mouthwash without therapy discontinuation with
that of a placebo solution (physiologic solution) used
as a mouthwash together with the discontinuation of
anticoagulant therapy. The therapeutic level of anti-
coagulant therapy in patients who used the tranex-
amic acid was between 3.0 and 4.5 of INR5; in
0030-4220/93/$1.00+. 10 29
30 Borea et al. ORAL SURG ORAL MED ORAL PATHOL
January 1993

Table I. Results from each group in induced bleedings were analyzed by the Mantel-
Tranexamic
Haenzel test; statistical significance was defined as
acid Control being indicated by a p value less than 0.05.

Patients 15 15
Sex (M/F) 5110 7/g
Age (mean + SD) 62.7 f 6.1 61.1 + 10
INR (normal value 1) 3.09 * 0.2 1.69 + 0.2
Dental mobility (l/2/3) 14/1/o 9/l/5
Complicated extraction 4/11 o/15
(Yes/No)
Spontaneous bleedings 1 2
(day after)
Induced bleedings 1 0
(day after)
Spontaneous bleedings 0 0
(after 1 week)
Induced bleedings 0 0
(after 1 week)
patients who used the placebo solution with discon-
tinuation of anticoagulant therapy the INR was be-
tween 1.5 and 2.5. Random numbers were used to as-
sign consecutive patients to treatment groups. The
randomization list was in possessionof the cardiolo-
gist who decided whether or not to discontinue the
anticoagulant treatment, recording the INR values
the day of the extraction and giving the patient the
bottle that contained a placebo or the tranexamic
acid. The patient was then sent to the oral surgeon
who was unaware of either the INR value or the con-
tent of the bottle. Before sutures were applied, the
surgical field was irrigated with 10 ml of the test so-
lution. After surgery the patients were instructed to
rinse their mouths with 10 ml of the assignedsolution
for 2 minutes and then to expectorate the solution (4
times a day for 7 days). Patients were also instructed
not to eat or drink within the first hour after using the
mouthwash. Acetominophen (paracetamol) was used
as a postoperative analgesic; aspirin and other non-
steroidal anti-inflammatory drugs were not allowed
for 1 week after surgery. The patients were instructed
to consume only liquids on the day after surgery and
to contact the department if postoperative bleeding
occurred that could not be controlled by compression
with gauze for 20 minutes. Patients were seenthe day
after surgery and again 1 week later. Postoperative
bleedings of more than 20 minutes duration were re-
corded along with the degree of induced bleeding by
touching the injured socket with a cotton pellet; the
degreeof induced bleeding was defined as follows: ( 1)
no bleeding; (2) bleeding less than 1 minute; (3)
bleeding more than 1 minute.
Differences between treatment groups in spontane-
ous bleedings of more than 20 minutes duration and
RESULTS
Spontaneous bleedings of more than 20 minutes
duration occurred in 1 of the 15 patients who received
tranexamic acid and in 2 of the 15 patients in the
control group (p = not significant). A small induced
bleeding occurred the day after surgery in only one
patient who received tranexamic acid. No relation-
ship seemsto exist between bleedings and tooth mo-
bility or complicated extraction (Table I).
DlSCUSSlON
These preliminary results have demonstrated a sig-
nificant hemostatic effect of tranexamic acid mouth-
wash after oral surgery despite a reduction in the co-
agulation levels in all patients at the time of surgery.
The greater clinical efficacy of tranexamic acid
mouthwash versus a placebo has been previously doc-
umented by Sindet-Pedersen et a1.,4who suggested
that the concentration of tranexamic acid in the saliva
after mouth rinsing 4 times a day is sufficient to re-
duce the incidence of postoperative bleeding compli-
cations, in accord with previously reported results of
treatment in patients with hemophilia.4, 6-8However,
it has not yet been clarified whether this method could
be a valid alternative to the usual method of discon-
tinuing anticoagulant treatment before oral surgery,
which is known to involve a risk of thromboembolism
and is unpleasant for the patient and the dentist. Data
from the present study showed no statistical differ-
encebetween the bleeding incidence after oral surgery
in patients who receive tranexamic acid and in
patients whose anticoagulant therapy was discontin-
ued. These results are also more significant when one
considers that a greater number of complicated
extractions and teeth with no mobility casually oc-
curred in the tranexamic acid group. There is some
controversy in the literature about the need to discon-
tinue anticoagulant therapy before oral surgery in
patients at risk for thromboembolism.‘, 9-13Prelimi-
nary data from this study seemto indicate that anti-
coagulation treatment doesnot need to be withdrawn
before oral surgery provided that local antifibrinolytic
therapy is instituted.
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Tranexamic acid as a mouthwash 31
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Reprint requests:
G. Borea
Clinica Odontoiatrica
via S. Vitale 59
40125 Bologna, Italy