The purpose of this nonrandom retrospective cohort study was to evaluate the impact of perioperative antibiotic on early outcomes, including postoperative pain, swelling, bleeding, and cyanosis, in patients undergoing dental implant placement before prosthetic loading. Seventy-five patients (45 men, 30 women) who had completed dental implant placement were included in the study. Patients who used perioperative antibiotics comprised the experimental group, and those who did not comprised the control group. The experimental group received 2 g amoxicillin + clavulanic acid 1 hour before surgery and 1 g amoxicillin + clavulanic acid twice a day for 5 days after surgery. The control group received no perioperative antibiotic therapy. Data on pain, swelling, bleeding, cyanosis, flap dehiscence, suppuration, and implant failure were analyzed on postoperative days 2, 7, and 14 and at week 12. No statistically significant difference was detected between the 2 groups with regard to pain and swelling on postoperative days 2, 7, and 14 and week 12 (P > .05), while the severity of pain and swelling were greater on day 2 than on days 7 and 14 and week 12 in both groups (P = .001 and P < .05, respectively). Similarly, no significant difference was found between the 2 groups with regard to postoperative bleeding and cyanosis. Although flap dehiscence was more severe on day 7 in the experimental group, no significant difference was found between the 2 groups with regard to the percentage of flap dehiscence assessed at other time points. Within the limitations of the study, it has been demonstrated that antibiotic use has no effect on implant failure rates in dental implant surgery with a limited number of implants. We conclude that perioperative antibiotic use may not be required in straightforward implant placement procedures. Further randomized controlled clinical studies with more patients and implants are needed to substantiate our findings.
Introduction
Although perioperative antibiotics are indicated for risk situations, such as infective endocarditis, immunosuppressed patients, and prolonged surgical interventions, the use of preoperative and/or postoperative antibiotics is commonly performed in dental implant surgery. However, there is no obvious treatment protocol for the use of perioperative antibiotics. On the other hand, insertion of an endosteal implant may be accompanied by various antibiotic protocols, including preoperative single or multiple dosing, postoperative single or multiple dosing for a few days, or preoperative dosing followed by postoperative dosing.1–4 Although some studies have indicated that preoperative antibiotics provide positive outcomes in dental implant surgery, no statistical significance has been reported to date.5,6
Researchers advocating antibiotic prophylaxis in dental implant surgery have recommended numerous antibiotic prophylaxis regimens to prevent implant failure. Esposito et al7 proposed that administering 2 or 3 g of amoxicillin 1 hour preoperatively or 1 g of amoxicillin 1 hour before the surgical intervention and 500 mg 4 times a day for 2 days postoperatively provides a remarkable increase in implant success and only recommended 2 g of amoxicillin before implant insertion. Likewise, Bryce et al8 suggested that administering 2 or 3 g of amoxicillin 1 hour preoperatively or 600 mg of clindamycin 1 hour preoperatively in the presence of penicillin allergy prevents implant complications in sinus augmentation or bone graft approaches. Sharaf and Dodson9 proposed several antibiotic prophylaxis regimens in implant surgery in healthy patients, including 2 g of amoxicillin before the surgery or 1 g of amoxicillin preoperatively and 500 mg amoxicillin 4 times a day postoperatively. In a previous systematic review of randomized controlled trials, Romandini et al10 reported that 3 g of amoxicillin 1 hour before implant surgery was the optimum antibiotic prophylaxis regimen for preventing implant failure. However, Khouly et al11 conducted a systematic review and meta-analysis, including perioperative antibiotic in dental implant placement, and investigated whether the use of prophylactic antibiotic and different antibiotic regimens affected postoperative implant infection in healthy patients. The authors reported that antibiotic use may not be indicated for preventing postoperative infection in dental implant surgery.11 Similarly, another systematic review evaluating the use of prophylactic antibiotics for infection in healthy patients during dental implant placement revealed that antibiotic use had no positive effect on clinical results.12 On the other hand, it has also been reported that long-term and/or excessive use of antibiotics may cause development of antibiotic-resistant bacteria and superinfection and/or side effects such as allergic reactions, diarrhea, toxicity, and drug interactions.13,14
Beside the role of antibiotic use in dental surgery, other factors may also affect the success rate of the implant or early outcomes, including oral hygiene, surgical approach, duration of surgery, skill of the practitioner, radiotherapy, chemotherapy, habits of the patients (eg, smoking, and metabolic diseases). Numerous systematic reviews in the literature have examined the effect of antibiotics on early outcomes, infection, and implant failure in implant surgery.10,12,15 However, in these studies, the number of implants and the duration of the surgery were not reported, and these factors are known to affect the clinical outcomes of patients. For this reason, evaluation of these parameters with or without antibiotic prophylaxis should be done in tandem so as to collect reliable data. Additionally, prolonged surgical procedures with large numbers of implants might affect early clinical outcomes.
In the present study, unlike the studies reported in the literature, we aimed to investigate how the use of perioperative antibiotics affects early outcomes, including pain, swelling, cyanosis, bleeding, infection, and implant failure.
Material and Methods
Study design
This nonrandom retrospective cohort study included 75 patients who underwent placement of endosteal implants at the Faculty of Dentistry between January 2015 and December 2016. This study was approved by the local institutional research ethics committee (No: B.30.2.AYD.0.00.00-480.2/153). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Exclusion criteria for the study were as follows:
Immunosuppression
Risk of infective endocarditis
History of chemotherapy and/or radiotherapy
Allergy to penicillin
Presence of acute or chronic infection in the oral cavity
Age under 18 years
Systemic disease that could cause healing problems
Pregnancy
Insertion of more than 3 endosteal implants
Use of different prophylactic or perioperative antibiotics by patients
Use of amoxicillin + clavulanic acid in different dose and/or duration
Patients who used perioperative antibiotics were defined as the experimental group, and those who did not use antibiotics were defined as the control group. The experimental group received 2 g of amoxicillin + clavulanic acid 1 hour preoperatively and 1 g twice a day for 5 days postoperatively, and the control group received no antibiotics perioperatively. Of all patients, 50 (66.7%) used 2 g of amoxicillin + clavulanic acid 1 hour preoperatively and 1 g of amoxicillin + clavulanic acid twice a day postoperatively for 5 days and 94.7% (n = 71) patients rinsed with benzydamine hydrochloride 0.15% and chlorhexidine gluconate 0.12% mouthwash 2 minutes before the implant surgery and were instructed to rinse twice a day for 1 week postoperatively. Patients in both groups used 500 mg paracetamol twice a day for 5 days. Periodontal health of the tissues was classified into 3 groups: healthy periodontal tissues (34.7%, n = 26), gingivitis (5.3%, n = 4), and chronic periodontitis (60%, n = 45) (Table 1).
A total of 123 endosteal implants were inserted in the patients (range = 1–3): 1 implant was inserted in 40 (53.3%), 2 implants in 22 (29.3%), and 3 implants in 13 (17.3%) patients (Table 1). All the surgical interventions were performed by 2 specialists, and the implants were inserted according to the manufacturer's standard surgery protocols. Five different implant brands were inserted: MIS (MIS Implant Technologies) (53.3%), ITI (Straumann Dental Implants, Institut Straumann AG) (20%), Implance (Implance Dental Implant System, AGS Medical) (12%), Biohorizons (BioHorizons Implant Systems, Inc) (10.7%), and BTK (BTK implants, Biotec) (4%) (Table 2).
Data collection and follow-up
To prevent interrater disagreement, all the clinical data were collected and analyzed by 2 specialists who performed the surgical procedures together. All measurements were evaluated separately by 2 experienced specialists. The intraclass correlation coefficient was used to determine intraoperator reliability for measurements performed by the 2 researchers, which yielded a 96.9% agreement rate. The outcomes were recorded on postoperative days 2, 7, and 14 and week 12. Of all patients, 66.7% used antibiotics and 33.3% were active smokers. The number of cigarettes smoked by each patient in a day ranged from 2 to 45, with a mean of 16.5 ± 11.7 cigarettes.
In the present study, we aimed to record and evaluate postoperative pain, swelling, bleeding, and cyanosis on postoperative days 2, 7, and 14 and week 12 (Table 3). For this reason, the severity of postoperative pain, swelling, bleeding, and cyanosis was evaluated by 2 examiners according to the following scale:
0 = Absent
1 = Mild
2 = Moderate
3 = Severe
Pain assessment was achieved using the visual analog scale, and the patients were informed that a score of 0 represented no pain, 1 to 3 represented mild pain, 4 to 6 represented moderate pain, and 7 to 10 represented severe pain.16 Bleeding was categorized as follows:
0 = No bleeding
1 = Petechial bleeding
2 = Moderate hemorrhage
3 = Moderate hemorrhage stopped with antihemorrhagic agents
The severity of swelling and cyanosis was scored based on the experience of the surgeons as follows: 0 = no swelling or cyanosis and 3 = severe swelling or cyanosis.
Statistical analysis
Statistical analyses were performed using IBM SPSS Statistics for Windows, version 22.0 (IBM Corp. released 2013). The methodology and results of the study were reviewed by an independent statistician. Descriptives were expressed as frequencies (n), mean, and standard deviation (SD). Variables were compared using Mann-Whitney U test, Wilcoxon signed-rank test, and Fisher exact test. A P value of <.05 was considered significant.
Results
The 75 patients comprised 45 (60%) men and 30 (40%) women with a mean age of 46.17 ± 14.79 years (range = 20–76 years) (Table 1). No significant difference was found among the assessments performed at all time points regarding the effect of antibiotic use on pain and swelling in the experimental group (P > .05) (Table 3). However, the severity of pain and swelling assessed on day 2 was significantly higher than the assessments performed on days 7 and 14 and week 12 in both groups (P = .001 and P < .05, respectively) (Table 3). On the other hand, no significant difference was found between the 2 groups with regard to the swelling and cyanosis assessed at all time points (Table 3). While the severity of bleeding assessed on day 2 was statistically higher than the assessments performed on days 7 and 14 and week 12 in the experimental group (P = .005, P = .005, P = .007, respectively), no significant difference was found among the assessments performed in the control group (Table 4). In the experimental group, the severity of cyanosis assessed on day 2 established no significant difference with the assessment performed on day 7, whereas it decreased significantly on day 14 and week 12 (P = .011 and P = .014, respectively). In contrast, no significant change was found among the assessments of cyanosis severity in the control group (P > .05) (Table 4).
No significant difference was found between the 2 groups with regard to the percentage of flap dehiscence; it was significantly higher on day 7 compared with the assessments performed at other time points in the experimental group. Early postoperative complications, including implant failure and suppuration, occurred in 1 patient each in the experimental group (Table 5).
Discussion
The present study examined the relationship between antibiotic usage and early outcomes of implant insertion and found that perioperative antibiotic use had no significant positive effect on early implant failure. None of the implants had prosthetic superstructure; therefore, no evaluation was performed regarding implant success after prosthetic loading. A prospective clinical study by Nolan et al17 assessed postoperative swelling, cyanosis, wound dehiscence, and suppuration on postoperative days 2 and 7 and reported that no difference was detected between the severity of these parameters assessed on day 2 and 7, while the severity of cyanosis was significantly higher on day 2 than day 7 in the experimental group. Additionally, flap dehiscence was rarely seen in the experimental and control groups, and no significant difference was found between the groups.17 Suppuration was observed in 2 patients who received no antibiotics preoperatively, and no significant difference was found between the 2 groups.17 Although swelling was detected in the control group, no significant difference was found between the severity of swelling assessed on days 2 and 7.17 The intensity of pain was greater in the control group than the experimental group.17 Moreover, although no difference was found between the 2 groups with regard to pain intensity on day 2, a significant difference was detected with regard to pain intensity on day 7.17
In the present study, no significant difference was found in both groups between the severity of pain, swelling, and bleeding assessed on days 7 and 14 and week 12 compared with day 2. In the experimental group, no significant difference was found between the severity of cyanosis on day 2 and day 7 (P > .05), and the severity of cyanosis decreased significantly on day 14 and week 12 compared with day 2 (P = .011 and P = .014, respectively) (Table 4). In the control group, however, no significant difference was found with regard to severity of cyanosis assessed on day 2 and the severity assessed on days 7 and 14 and week 12 (Table 3). Our findings were similar to those reported by Nolan et al,17 although that study had a short follow-up period.
Sánchez et al18 conducted a systemic review and meta-analysis and reported that the administration of single-dose oral amoxicillin preoperatively may be useful for preventing dental implant failure after dental implant surgery. The authors also noted that the use of a postoperative amoxicillin regimen may not be effective in preventing postoperative infection and/or dental implant failure.18 In a similar way, Esposito et al7 concluded that short-term antibiotic treatment (eg, 2 g or 3 g amoxicillin 1 hour before implant surgery or 1 g amoxicillin 1 hour before implant surgery and postoperative 500 mg amoxicillin 4 times a day for 2 days) decreased early implant failure. In contrast, Ahmad and Saad19 indicated that there was no significant difference between the success rate of patients who used prophylactic antibiotics and that of placebo group; they suggested that there was no clear reason for the use of prophylactic antibiotics in dental implant surgery. In a systematic review, Surapaneni et al20 reported that although use of prophylactic antibiotics is not compulsory for dental implant surgery, it is likely to increase long-term survival and success rates and minimize postoperative infections. In the present study, the patients in the experimental group received 2 g of amoxicillin + clavulanic acid 1 hour preoperatively and 1 g twice a day for 5 days postoperatively, and no significant difference was found between the 2 groups with regard to implant success (Table 5). However, flap dehiscence was significantly more severe on day 7 in the experimental group than the control group and implant failure and suppuration occurred in 1 patient each in the experimental group. Besides perioperative antibiotic usage, several other parameters may affect clinical outcomes, including contamination of dental implant, duration of dental implant surgery, experience of dentist or surgeon, flap design, absence or presence of vertical incision, quality and quantity of the bone, suture material, surgical approach (immediate, standard approach, implant system protocol, bone augmentation), health status of periodontal tissues (gingivitis, periodontitis), and oral hygiene.
Our study was limited in several ways. First, the study included only patients who underwent insertion of a maximum of 3 implants. Although several studies have included more patients and implants, these studies provided no information regarding the number of implants inserted in each patient, which could be an effective factor for duration of surgery, healing process, complications, and success rate. In future randomized clinical trials, the effect of antibiotic use on early outcomes in patient groups with a different number of implants might be evaluated. Second, our study included no evaluation of surgical technique (standard, immediate, guided tissue regeneration), location of implantation (maxillary or mandible anterior/posterior region), quality and quantity of bone, and differences among prophylactic or perioperative antibiotic regimens. Further multicentric studies administering the same procedures with a larger sample size may provide reliable outcomes related to the effect of antibiotic prophylaxis in dental implant surgery.
Conclusion
The results indicated that perioperative antibiotic use may not be indicated in straightforward implant placement procedures. Within the limitations of the study, it has been demonstrated that antibiotic use has no effect on implant failure rates in dental implant surgery with a limited number of implants. Additionally, no significant difference was detected between the experimental and control groups with regard to swelling, cyanosis, and percentage of flap dehiscence. Further randomized controlled clinical studies with more patients and implants are needed to substantiate our findings. An ethically approved prospective study should be conducted to validate the conclusions of this retrospective study.
Note
The authors declare that they have no conflicts of interest with the contents of present article.