Evaluating the Need of Continuing the Antiplatelet Drug Therapy in Patients Undergoing Minor Oral Surgical Procedures.

BACKGROUND: Dental treatment in patients on antiplatelet drug therapy is a long standing debate. Discontinuation of medication increases the risk of thrombotic complications, whereas continuation leads to increased postoperative bleeding. AIM: We conducted this prospective cross-sectional study to assess risk of bleeding in patients continuing antiplatelet medication while performing minor oral surgical procedures such as single or multiple teeth extraction, transalveolar extraction of third molar, biopsy, and alveoloplasty.
MATERIALS AND METHODS: We calibrated the steps taken to achieve hemostasis, time taken to arrest bleeding, and correlated time taken to achieve hemostasis in patients under antiplatelet drug therapy (Group A [n = 64] - aspirin, Group B [n = 36] - aspirin and clopidogrel) and in patients without any drug therapy (Group C [n = 100] healthy patients).
RESULTS: Out of 200 patients, Level 1 hemostatic measures were required for 129 (64.5%) patients, Level 2 hemostatic measures were taken for 68 (34.0%) patients, and Level 3 hemostatic measures were taken for 3 (1.5%) patients. Chi-square test conducted to compare the local hemostatic measures taken for minor oral surgical procedure for all groups was statistically significant (P ≤ 0.001).
CONCLUSION: Overall, there was no postoperative bleeding within 24 h of extraction in any patient group. In conclusion, surgical procedures can be safely accomplished in patients receiving single or dual antiplatelet therapy when appropriate local hemostatic measures are taken. Copyright:

INTRODUCTION

Antiplatelet therapy is to treat thromboembolic disorders, but it causes hemorrhages. Aspirin is the drug in regular practice. Clopidogrel is another alternative for aspirin.[12] Dental patients under antiplatelet therapy are at a high risk and it is always a debate to stop it or not prior procedure. Studies recommended discontinuing aspirin usage for 7–10 days or at least for duration of 3 days.[34] Thromboembolic events can occur, causing severe cardiac complications.[56] Most of the dental surgical procedures carry a low risk of bleeding, and any excessive bleeding can be controlled by local hemostasis.[78] Platelet interaction and cardiovascular disease progression remain an unsolved riddle for many years.[910] Therefore, we conducted this study to assess risk of bleeding in patients continuing antiplatelet medication when performing minor oral surgical procedures.

MATERIALS AND METHODS

This is a prospective study conducted among the patients attending the outpatient department of Oral and Maxillofacial Surgery, Vyas Dental College and Hospital, Jodhpur. Institutional ethical clearance and informed consent were obtained prior to the commencement of the study. Based on simple random sampling (coin toss method), a total of 200 patients requiring minor oral surgical procedures were recruited into the study between January 2017 and August 2018. Patients on single or dual antiplatelet therapy and patients with normal blood and coagulation profile were included in the study. On the other hand, medically compromised patients such as uncontrolled diabetes, hypertension or other endocrine disorders, and pregnant and lactating women were excluded from the study. Patients on anticoagulant therapy, birth control pills, hormonal replacement therapy, nonsteroidal anti-inflammatory drugs, discontinued antiplatelet therapy, and alcoholic patients were excluded from the study. Based on their medication, all patients were divided into 3 groups: Group A included patients on mono drug therapy of antiplatelet drugs taking a dosage of 75 mg or 150 mg of aspirin, Group B included patients on multiple drug therapy taking a dosage of 75 mg clopidogrel along with aspirin, and Group C included patients not taking any antiplatelet drug therapy (control group). The complications of performing the surgical procedures with uninterrupted antiplatelet therapy were explained to the patients before the commencement of the procedure. Preoperatively, a detailed case history was recorded along with the vital signs, bleeding time, clotting time, and additionally, dosage and duration of antiplatelet therapy for Group A and Group B patients. All patients received a local anesthetic injection (2% lignocaine with vasoconstrictor) and all the oral surgical procedures were done by the same operator as atraumatically as possible. Postoperatively, granulation tissue, sharp bony edges, or foreign bodies were removed from the surgical site. Gel foam was inserted at the surgical site and was sutured with 3-0 Mersilk using a horizontal mattress technique or interrupted technique or locking continuous technique. The patient was instructed to bite onto a pressure pack placed over the surgical site for 1 h. After 1 h, the wound was inspected for any evidence of bleeding. Levels of hemostatic measures taken were categorized from Level 1 to Level 5:[11] Level 1 - pressure pack application, Level 2 - suturing, Level 3 - local hemostatic agents and suturing, Level 4 - surgical diathermy, and Level 5 - platelet transfusion. Antibiotics and analgesics were prescribed to the patients and were asked to continue his/her regular dose of aspirin. All the patients were given postoperative instructions and were instructed to report back in case of hemorrhagic complications. The patients were recalled after 24 h and examined for any uncontrolled bleeding. Sutures were removed after 7 days. According to Lockhart & Lillis, 2003,[1213] clinically significant bleeding can be classified as (1) continues beyond 12 h; (2) causes the patient to call or return to the dental practitioner or to the accident and emergency department; (3) results in the development of a large hematoma or ecchymosis within the oral soft tissues; or (4) requires a blood transfusion. Statistical analysis was performed with SPSS 23.0 (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp. Released 2015). The results of normality tests such as Kolmogorov–Smirnov and Shapiro–Wilks revealed that the common variable (Age) followed normal distribution. Therefore, to compare the mean age among the 3 groups, one-way ANOVA was applied. To compare proportions between groups, Chi-square test was applied, and if any expected cell frequency was <5, Fisher's exact test was used. All statistical tests were 2-sided and were considered significant at 5% (α = 0.05).

RESULTS

During the study period, a total of 450 patients were screened, and 200 patients meeting the inclusion and exclusion criteria were enrolled. Out of 200 patients, the mean age of Group A patients was 58.06, for Group B patients was 56.42 years, and 56.65 years for Group C patients, and the mean age for total patients (200) was 57.06 years. In Group-A, out of 64 patients, 34 were male and 30 were female. In Group B, out of 36 patients, 21 were male and 15 were female. In Group C (control group), 51 patients were male and 49 patients were female. Out of 200 patients, 106 (53.0%) patients were male and 94 (47.0%) patients were female. Comparison of age and gender with bleeding and hemostasis was statistically insignificant. Out of 200 patients, 108 (54.0%) patients had undergone extraction, 12 (6.0%) patients had undergone alveoloplasty, 25 (12.5%) patients underwent multiple extractions, biopsy was performed on 7 (3.5%), tori removal was done on 6 (3.0%) patients, and transalveolar extractions on 42 (21.0%) patients. Chi-square test showed no statistically significant difference among the 3 groups due to varying distribution of patients. Out of 200 patients, Level 1 hemostatic measures were required for 129 (64.5%) patients, Level 2 hemostatic measures were taken for 68 (34.0%) patients, and Level 3 hemostatic measures were taken for 3 (1.5%) patients. Chi-square test conducted to compare the local hemostatic measures taken for minor oral surgical procedure for all groups was statistically significant (P ≤ 0.001). Overall, there was no postoperative bleeding within 24 h of extraction in any patient group. Out of 200 patients, alveoloplasty was performed in 12 patients, out of which hemostasis was achieved in 6 (50%) patients by Level 1, which is associated with single tooth, and in other 6 (50%) patients, hemostasis was achieved by Level 2. Out of 200 patients who underwent various minor surgical procedures, multiple extractions were done in 25 patients. Level 1 hemostatic measure was done in 19 (76.0%) patients; Level 2 hemostatic measure was done 5 (20.0%) patients; and Level 3 in hemostatic measure in 1 (4.0%) patient. All the 7 biopsy patients required Level 2 hemostatic measures. In total 34 patients were included in Group A, Level 1 hemostatic agent was used for 31 (91.2%) patients, Level 2 hemostatic agent was used for 2 (5.9%) patients, and Level 3 hemostatic agent was used in 1 (2.9%) patient [Table 1]. In total, five patients underwent alveoloplasty, out of which Level 1 hemostatic agent was used for 3 (60%) patients and Level 2 hemostatic agent was used in 2 (40%) patients. Out of 64 patients, nine patients underwent multiple extractions and Level 1 hemostatic agent is used for 8 (88.9%) patients (P ≤ 0.001, highly significant). In total, 36 patients were included in Group B, out of which 18 extraction patients; Level 1 hemostatic measure was used for 17 patients (94.4%) patients and Level 2 hemostatic agent was used for 1 (5.6%) patient [Table 2]. Out of the 3 alveoloplasty patients, Level 1 hemostatic agent was used for 1 (33.3%) patient and Level 2 hemostatic agent was used in 2 (66.7%) patients. Among the multiple extraction subgroup, Level 1 hemostatic agent was used for 1 (25.0%) patient, Level 2 hemostatic agent was used for 2 (50%) patients, and Level 3 hemostatic agent was used for 1 (25.0%) patient (P ≤ 0.001, highly significant). Out of the 100 Group C patients, Level 1 hemostatic agent was used for 56 (100%) patients. Level 2 hemostatic agent was used for all the 5 biopsy (100%) patients and 2 tori removal patients (100%) [Table 3] (P ≤ 0.001, highly significant).

Table 1

Local hemostatic measures taken for Group A (Aspirin) patients

Procedure	Level				P
	Level 1, n (%)	Level 2, n (%)	Level 3, n (%)	Total, n (%)
Extraction	31 (91.2)	2 (5.9)	1 (2.9)	34 (100.0)	<0.001
Alveoloplasty	3 (60.0)	2 (40.0)	0 (0.0)	5 (100.0)
Multiple extraction	8 (88.9)	1 (11.1)	0 (0.0)	9 (100.0)
Biopsy	0 (0.0)	2 (100.0)	0 (0.0)	2 (100.0)
Removal of tori	0 (0.0)	3 (100.0)	0 (0.0)	3 (100.0)
TA extraction	0 (0.0)	11 (100.0)	0 (0.0)	11 (100.0)
Total	42 (65.6)	21 (32.8)	1 (1.6)	64 (100.0)

TA: Trans Alveolar

Table 2

Local hemostatic measures taken for Group B (Aspirin+clopidogrel or dual antiplatelet drugs)

Procedure	Level				P
	Level 1, n (%)	Level 2, n (%)	Level 3, n (%)	Total, n (%)
Extraction	17 (94.4)	1 (5.6)	0 (0.0)	18 (100.0)	<0.001
Alveoloplasty	1 (33.3)	2 (66.7)	0 (0.0)	3 (100.0)
Multiple extraction	1 (25.0)	2 (50.0)	1 (25.0)	4 (100.0)
Biopsy	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Removal of tori	0 (0.0)	1 (100.0)	0 (0.0)	1 (100.0)
TA extraction	0 (0.0)	10 (100.0)	0 (0.0)	10 (100.0)
Total	19 (52.8)	16 (44.4)	1 (2.8)	36 (100.0)

TA: Trans Alveolar

Table 3

Level of hemostatic measures taken for Group C

Procedure	Level				P
	Level 1, n (%)	Level 2, n (%)	Level 3, n (%)	Level 3, n (%)
Extraction	56 (100.0)	0 (0.0)	0 (0.0)	56 (100.0)	<0.001
Alveoloplasty	2 (50.0)	2 (50.0)	0 (0.0)	4 (100.0)
Multiple extraction	10 (83.3)	2 (16.7)	0 (0.0)	12 (100.0)
Biopsy	0 (0.0)	5 (100.0)	0 (0.0)	5 (100.0)
Removal of tori	0 (0.0)	2 (100.0)	0 (0.0)	2 (100.0)
TA extraction	0 (0.0)	20 (95.2)	1 (4.8)	21 (100.0)
Total	68 (68.0)	31 (31.0)	1 (1.0)	100 (100.0)

TA: Trans Alveolar

DISCUSSION

According to Brennan et al., immediate postoperative bleeding lasts about 15 min in healthy patients after which the wound continues to release small amounts of blood up to 12 h, which is part of physiological process.[1314] According to the American College of Surgeons advanced trauma life support classification, <750 ml (15% of total blood volume) blood loss will not cause any significant alteration in the hemodynamic balance.[13] In our study, no patient reported back with persistent bleeding; only 1 (2.9%) patient from Group A was managed with Level 3 hemostatic measures, and the rest of the patients were managed with pressure pack and suturing. Cardona-Tortajada et al.[15] reported late-onset (24 h) postextraction bleeding in 17% of their 155 antiplatelet-treated patients; the complications reported were within the manageable range of private dental clinical setting. Postextraction monitoring period was just 10 min, whereas in our study, we monitored the patients for bleeding after 1 h and after 24 h. None of the patients had bleeding after 24 h of procedure. In a study by Lillis et al.[16] and Shah et al.,[17] bleeding complications were noted more when extractions were done in periodontally compromised dentition than in carious teeth. Even in our study, periodontitis patients from Group A and Group B showed increased bleeding time. In our study, we did not measure the platelet count to assess the hemorrhagic risk; also, platelet function to assess antiplatelet resistance was not measured before the procedure. Other limitation would be including only patients on aspirin and clopidogrel. Patients on other antiplatelet drugs were excluded from the study.

CONCLUSION

The Oral Medicine and Oral Surgery Francophone Society stated that it is unnecessary to interrupt antiplatelet therapy prior to dental procedures. The bleeding risk is very low and local hemostatic measures are usually successful. With the advent of newer antiplatelet drugs such as protease-activated receptor-1 antagonists, which are not associated with any significant bleeding, it will help clear this longstanding debate regarding the usage of antiplatelet medication prior to surgical procedures.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.