European Journal of Cardiovascular Medicine

Antimicrobial resistance has emerged as one of the most pressing global health threats, undermining decades of progress in modern medicine¹. The increasing resistance of bacteria to antimicrobial agents poses a direct danger to human health and challenges the effectiveness of existing therapeutic approaches. When bacteria develop resistance, diseases that were once readily treatable become more difficult to manage, leading to higher morbidity, mortality, and healthcare costs. This phenomenon affects not only individual patients but also entire societies and humanity at large. It is well recognized that the overuse and misuse of antibiotics accelerate the development of resistance, reinforcing the principle that antibiotics should be prescribed only when truly necessary. Therefore, antibiotic use must be judicious, evidence-based, and aligned with scientifically verified guidelines to prevent overuse and minimize the risk of resistant strains proliferating. Within the realm of dentistry, dental implant surgery is among the most common and predictable procedures, widely utilized for replacing missing teeth and achieving high success rates.² However, one of the ongoing debates centers around the role of systemic antibiotic prophylaxis in preventing postoperative infection and early implant failure. Historically, prophylactic regimens were advocated, with protocols recommending Penicillin V administered orally one hour before surgery and continued for 10 days postoperatively.³ Despite being widely cited, early guidelines lacked robust scientific evidence and did not establish a standardized protocol for antibiotic prophylaxis in implant dentistry.A shift in understanding came in 2013 with a landmark Cochrane systematic review and a meta-analysis that pooled data from six randomized controlled trials (RCTs). This analysis demonstrated that a single preoperative dose of amoxicillin administered orally one hour before implant placement significantly reduced the risk of early implant failure compared with placebo⁴. Based on these findings, the authors suggested that a routine single dose of 2 g amoxicillin immediately prior to surgery could be beneficial. Nevertheless, the magnitude of benefit was modest: the absolute risk reduction was reported as 4%, and the number needed to treat (NNT) to prevent one case of implant failure was calculated at 25. This raised questions regarding the balance between potential benefits and the broader implications of antibiotic use⁵. A subsequent systematic review and meta-analysis, which limited its inclusion to RCTs directly comparing antibiotic prophylaxis with placebo, found an even lower absolute risk reduction of 2%, yielding an NNT of 50. From this perspective, the authors argued that prophylactic antibiotics may not be beneficial for otherwise healthy patients undergoing uncomplicated implant procedures, particularly when the risks of unnecessary antibiotic exposure are considered. Supporting this interpretation,⁶ the European Association for Osseointegration (EAO) released a consensus statement in 2015, concluding that antibiotic prophylaxis had no clear beneficial effect in straightforward implant cases.Despite these findings, the debate has not been fully resolved. In the years since the Cochrane review, multiple systematic reviews and meta-analyses have been published, all reaffirming that antibiotic prophylaxis can reduce the risk of early implant loss. Yet, they also consistently emphasize that the absolute risk reduction is small and subject to varying interpretation⁷. Some scholars argue that the small reduction is nonetheless clinically significant and advocate for prophylaxis, while others caution against indiscriminate antibiotic use given the global resistance crisis and the potential for adverse drug reactions. Adding to the complexity, a recent consensus report from the Italian Academy of Osseointegration diverged from the EAO’s 2015 position and recommended the use of a single prophylactic dose of antibiotics even in straightforward cases. These contrasting views illustrate the uncertainty and divided opinions within the scientific community.⁸ One of the limitations across all existing systematic reviews is the lack of new, large-scale, well-conducted, placebo-controlled RCTs since the earlier analyses. Consequently, the strength of the evidence base remains limited, and current recommendations continue to rely on relatively small datasets.Given this backdrop, there is a compelling need for high-quality clinical trials to clarify the role of antibiotic prophylaxis in dental implant surgery.⁹ The aim of the present large-scale multicenter RCT is to address this gap by comparing the effects of a single 2 g dose of amoxicillin taken orally one hour before surgery against an identical placebo in patients who are healthy or relatively healthy¹⁰. The study hypothesis is that the difference in early implant failure and postoperative infections between patients receiving prophylactic antibiotics and those receiving placebo will be small and of low clinical relevance. By providing robust, contemporary evidence, this trial seeks to inform best practices in implant dentistry, balancing the potential benefits of preventing implant loss against the urgent need to avoid unnecessary antibiotic use in the era of antimicrobial resistance.

AIM

The aim is to evaluate the effect of prophylactic antibiotics in dental implant surgery at tertiary care center

This study was designed as a prospective, multicenter, randomized, placebo-controlled, double-blinded clinical trial to evaluate the effect of antibiotic prophylaxis on outcomes of dental implant surgery.The trial was conducted at Department of Dentistry, Govt. Medical college, Dungarpur between 2022 to 2023 for 1 yr.Participants were adults aged >18 years requiring dental implant placement. Patients with immunodeficiency, severe diabetes, severe systemic disease, prior head and neck radiotherapy, acute or chronic oral infection, ongoing antibiotic therapy, penicillin allergy, previous bisphosphonate treatment, implant surgery requiring substantial bone augmentation, or implants planned for immediate loading within 2 weeks were excluded. All eligible participants provided written informed consent prior to enrollment.

Table 1: Baseline Demographic and Clinical Characteristics of Study Participants

Age distribution showed that most participants were between 41–60 years, while fewer were younger than 40 or older than 60. The groups were balanced in gender, smoking status, and diabetes prevalence, with 35 males and 28 females in the antibiotic group versus 33 males and 29 females in the placebo group, and similar proportions of smokers and diabetic patients in both groups.

Table 2: Distribution of Implants According to Jaw Site

In the study, implants were placed in both jaws, with 36 patients in the antibiotic group and 34 in the placebo group receiving implants in the mandible, while 27 and 28 patients, respectively, received implants in the maxilla. The distribution of implant sites was similar between the two groups.

Table 3: Distribution of Implant Systems and Number of Implants per Patient

The study included multiple implant systems, with Straumann, Stra, Nobel, and Southern implants distributed similarly between the antibiotic and placebo groups. Most patients received a single implant (49 in the antibiotic group and 47 in the placebo group), while the remaining patients received multiple implants.

Table 4: Postoperative Complications in Study Participants

Postoperative complications were low in both groups, with early infections occurring in 2 patients (3.2%) in the antibiotic group and 6 patients (9.7%) in the placebo group, while late infections were seen in 1 patient (1.6%) and 4 patients (6.5%), respectively. Wound dehiscence and swelling were also comparable, affecting a small number of patients in both groups.

Table 5: Implant Survival and Failure Rates at Follow-Up

Implant survival rates were high in both groups, with 98.4% in the antibiotic group and 96.8% in the placebo group at 3 months, and 96.8% versus 95.1% at 6 months. At 12 months, survival was 96.8% in the antibiotic group and 93.5% in the placebo group, with implant failure occurring in 2 patients (3.2%) and 4 patients (6.5%), respectively.

The study included 125 patients requiring dental implants, divided into an antibiotic group (n=63) and a placebo group (n=62). The mean age of participants was 49.6 ± 11.2 years in the antibiotic group and 48.9 ± 12.0 years in the placebo group. Age distribution showed that the majority of patients were between 41 and 60 years, with smaller proportions in the younger (18–40 years) and older (>60 years) age groups. The gender distribution was balanced, with 35 males and 28 females in the antibiotic group compared to 33 males and 29 females in the placebo group. Smoking prevalence was similar between groups, with 17.5% in the antibiotic group and 16.1% in the placebo group. The proportion of patients with diabetes was also comparable, at 9.5% and 11.3% respectively. Overall, there were no significant differences between groups in baseline demographic or clinical characteristics. This indicates that the randomization effectively created comparable groups, minimizing confounding factors for the study outcomes.Similarly, in a study by Momand P, Becktor JP et al¹¹ The study cohort (n = 474), comprising the antibiotic group(n = 239) and the placebo group (n = 235), received 757 implants.Gender distribution was fairly equal, 239 males and 235 females, and mean age in the entire cohort at time of surgery was 57.4 (±13.9)years. Gender distribution was also fairly equal in each group, and the mean age of the two groups did not differ significantly

Implants were placed in both the mandible and maxilla among the study participants. In the antibiotic group, 36 patients received implants in the mandible and 27 in the maxilla. In the placebo group, 34 patients received implants in the mandible and 28 in the maxilla. The distribution of implant sites was similar between the two groups, indicating balanced allocation. This ensured that the site of implant placement did not introduce bias in the study outcomes. Overall, both groups were comparable in terms of jaw receiving implants.

The study involved the use of four different implant systems: Straumann, Stra, Nobel, and Southern. In the antibiotic group, 25 patients received Straumann implants, 15 received Stra, 18 received Nobel, and 5 received Southern implants. In the placebo group, 24 patients received Straumann, 15 received Stra, 16 received Nobel, and 7 received Southern implants. Most patients in both groups received a single implant, with 49 in the antibiotic group and 47 in the placebo group. The remaining patients received multiple implants, 14 in the antibiotic group and 15 in the placebo group. The distribution of implant systems and the number of implants per patient were comparable between the two groups. This balanced allocation minimized potential bias related to implant type or number in evaluating study outcomes.Similarly, in a study by Momand P, Becktor JP et al¹¹Of the entire study cohort, 281 patients (59.3%) received implants from Straumann; 149 (31.4%), Astra; 49 (10.3%), Nobel Bio-Care; and 3 (0.6%), Southern. No difference in primary outcome was noted regarding the different implant systems that were used. The majority were one-stage surgeries (373 implants, 78.7%). Some sur-geries included a sinus lift (21 patients, 4.4%), minor bone augmenta-tion (78 patients, 16.5%) or implant placement with guided bone generation (GBR)

Postoperative complications were observed in both the antibiotic and placebo groups, although the overall incidence was low. Early infections within 7 days occurred in 2 patients (3.2%) in the antibiotic group compared to 6 patients (9.7%) in the placebo group. Late infections after 7 days were reported in 1 patient (1.6%) in the antibiotic group and 4 patients (6.5%) in the placebo group. Wound dehiscence affected 2 patients (3.2%) in the antibiotic group and 3 patients (4.8%) in the placebo group. Swelling was reported in 10 patients (15.9%) in the antibiotic group and 12 patients (19.3%) in the placebo group. These results indicate a slightly lower rate of early and late infections in the antibiotic group. Overall, the groups were comparable in terms of postoperative complications, suggesting that antibiotic prophylaxis may have a limited impact.

Implant survival was consistently high in both the antibiotic and placebo groups throughout the follow-up period. At 3 months, 62 patients (98.4%) in the antibiotic group and 60 patients (96.8%) in the placebo group had surviving implants. At 6 months, survival rates were 96.8% in the antibiotic group and 95.1% in the placebo group. At 12 months, 61 patients (96.8%) in the antibiotic group and 58 patients (93.5%) in the placebo group maintained implant survival. Implant failure occurred in 2 patients (3.2%) in the antibiotic group and 4 patients (6.5%) in the placebo group. These results indicate slightly better outcomes with antibiotic prophylaxis, although overall survival remained high in both groups. The findings suggest that antibiotic use may provide limited additional benefit in routine dental implant procedures.Esposito M, Grusovin MG, Maghaireh H et al⁶ showed One hundred and fifty-eight patients were evaluated in each group and none dropped out at 4 months. Two prostheses and two implants failed in the antibiotics group, compared with four prostheses and nine implants in the placebo group. There were no statistically significant differences for prosthesis failures, implant losses, complications and side effects.

The study concludes that antibiotic prophylaxis in routine dental implant surgery provides only a modest benefit. Implant survival was high in both the antibiotic and placebo groups, and postoperative complications were generally low. While the antibiotic group showed slightly fewer early and late infections and marginally higher implant survival rates, the differences were not substantial. Baseline characteristics, implant sites, and implant systems were well balanced between groups, indicating that randomization was effective. Overall, the findings suggest that routine use of antibiotics may not be necessary for healthy patients undergoing standard dental implant procedures, and prophylactic antibiotics should be reserved for patients with specific risk factors or compromised systemic health. This approach may help reduce unnecessary antibiotic use and combat the growing issue of antibiotic resistance.

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