Effect of preoperative antibiotic use on the implant success rate: a retrospective cohort study of cefixime and ornidazole in China

Abstract

Background

This study aims to enhance the current clinical understanding of prophylactic antibiotic treatment in China before implant surgeries, and improve the experience and adherence of patients who undergo implant procedures. 

Methods

Patients eligible for inclusion in the past six years were divided into two groups of 500 patients each. Patients in the medication group received one 500 mg cefixime tablet and one 500 mg ornidazole tablet 0.5 hours before implantation. Patients in the non-medicated group did not receive any medicine. Patients were evaluated at two follow-ups: 7–14 days and 3–6 months after implant surgeries. The primary outcome was implant failure, which was characterized as implant detachment or complete loss during follow-ups, implant mobility (clinical mobility >1 mm) detected by surgeons when manually tightening abutments at the second follow-up (3–6 months after surgeries), or complications requiring clinical intervention occurred, including peri-implant bone resorption exceeding acceptable levels. Secondary outcomes were postoperative infection and adverse events. We statistically analyzed study outcomes using the Pearson Chi-square test, Fisher's exact test, and a multiple logistic regression model to evaluate differences between the two groups. P values less than 0.05 or 95% confidence intervals of relative risk or odds ratio values excluding one were considered statistically significant.

Results

We noted implant failures (medication group: four patients, 0.8% and non-medicated group: three patients, 0.6%) and postoperative infections (medication group: 23 patients, 4.6% and non-medicated group: 25 patients, 5.0%) were no statistically significant difference between the two groups. However, adverse events showed a statistically significant increase in the medication group (medication group: 111 patients, 22.2% and non-medicated group: 21 patients, 4.2%), including nausea, vomiting, hypersomnia, dizziness, and diarrhea. There was a statistically non-significant increase in fever in the non-medicated group. No statistically significant evidence existed in preventing postoperative infection between the two groups across smoking status, age, implant system, number of implants (1, 2–3, and ≥4), sinus elevation surgery, implant placement, and guided bone regeneration surgery.

Conclusions

Antibiotic prophylaxis using ornidazole in conjunction with cefixime in implant surgery may not have clinical benefits but significantly increases adverse events. Therefore, the necessity of prophylactic antibiotic use in healthy patients before implant surgeries needs to be reconsidered.

Background

Tooth loss and partial edentulism are common oral health problems, especially among older adults. According to the fourth national oral health epidemiological survey report, the incidence of dental defects and loss in the 65-74-year-old population is 10.51%, and the common causes are caries and periodontitis [1]. Although the traditional removable dentures and fixed dentures can repair a large number of dental defects and losses, it has some disadvantages, such as low chewing efficiency, poor comfort, and adverse effects on aesthetics [2], prompting the need for more advanced alternatives like implants.

The implant is a substitute for missing or defective natural teeth. It has many advantages, such as high chewing efficiency, no damage to adjacent teeth, a comfortable and beautiful appearance, a stable and reliable connection, a wide range of applications, and so on [3]. Implant restoration has become the preferred treatment for partial or total toothless patients [2]. Large-scale studies have reported that the success rate of implants was between 75% and 97%, and oral infection was a common factor resulting in implant failure [4–7]. Studies have shown that invaded bacteria will adhere to the implant’s surface and aggregate to form plaque biofilm, leading to peri-implantitis, early postoperative infection, and implant failure [8]. Previous studies indicate that about 28% of patients undergoing implant surgeries may experience peri-implantitis over time [9], and effective prevention methods for peri-implantitis primarily include maintaining proper oral hygiene, implementing regular professional maintenance, and addressing risk factors [10, 11]. To sum up, the incidence of bacterial infection must be effectively reduced to improve the success rate of implant surgeries.

Mixed bacterial flora infection is often detected in failed implants, such as Gram-negative corynebacteria, Clostridiums, Actinomycetes, Porphyromonas gingivalis, and Prevotella intermedia [12]. In many developed countries like the United States, it is well established and accepted that prophylactic use of antibiotics prior to implant surgeries does not significantly improve outcomes. However, antibiotic prophylaxis is still frequently used in China’s implant surgeries [13–15]. Nevertheless, the growing antibiotic resistance of microbes is an international issue and directly threatens human health [16–18]. In China, there is insufficient evidence to develop clear clinical guidelines in this field, so conducting a retrospective cohort study is necessary to explore the effect of antibiotic prophylaxis.

The use of ornidazole and cefixime as a combination therapy for preventing bacterial infections before surgeries is widespread in China. Ornidazole belongs to the third-generation nitroimidazole antibiotics, which can kill various anaerobic bacteria by breaking the DNA helix structure of pathogenic bacteria and preventing their replication and transcription [19]. The third-generation oral cephalosporin cefixime works well against various Gram-positive bacteria, including Staphylococcus aureus and Streptococcus pneumoniae, as well as Gram-negative bacteria, including Escherichia coli and Klebsiella pneumoniae. Cefixime is particularly suitable for targeting aerobic bacteria present in dental surgeries. Theoretically, the combined approach of ornidazole and cefixime can effectively cover both aerobic and anaerobic bacteria, improve the therapeutic effect, and reduce the occurrence of antibiotic resistance [20, 21]. However, there are few studies on the antibacterial effect of the combined use of these two drugs before implant surgeries, which is worthy of further study.

In this study, we performed a retrospective cohort analysis to investigate the effects of ornidazole and cefixime on the implant success rate in patients who were in good or reasonably good health and experienced implant procedures. It is anticipated that there would be minimal and clinically insignificant differences in early implant failure and postoperative infection between individuals who received ornidazole and cefixime before surgeries and those who did not. In other words, there was no significant difference in the implant success rate between the medication group and the non-medicated group.

Methods

Study design

This retrospective cohort study was conducted at Changsha Stomatological Hospital between January 1 st, 2019 and December 31 st, 2024. Patients included in this study were “healthy or relatively healthy”, defined as ASA grades I-II (without serious systemic diseases).

According to earlier research, the rate of early implant loss with antibiotic prophylaxis was 2%, whereas the rate without antibiotic prophylaxis was 5% [22]. Taking a type one error of 0.05 and a power of 80% into consideration, 500 patients needed to be included in each group to detect a significant difference between the medication and non-medicated groups. All the treating clinicians were surgeons who routinely perform implant procedures.

Changsha Stomatological Hospital is a Grade Three, Class A stomatology specialized hospital and the first medical institution to carry out implant surgeries in Hunan Province, China. Hence, many patients will participate in our study there.

Patients older than eighteen needing an implant surgery were eligible to participate in the study. In order to simulate real-world clinical practice, mild surgical complexity such as crestal maxillary sinus floor elevation, GBR (guided bone regeneration) surgery was allowed. Crestal maxillary sinus floor elevation is indicated for implantation in the maxillary posterior teeth area with alveolar bone height of 4–7 mm, using Summers bone chisel (3i, United States) or percussion and capping method. The GBR surgeries were classified as simultaneous and simple bone augmentation surgeries, which only used absorbable collagen membranes (Bio-Gide^®, Geistlich Pharma AG, Switzerland) and bone graft particles to cover the exposed areas of implants (bone defects < 3 mm) and were completed concurrently with implant procedures, without the need for additional incisions or staged surgeries. They were categorized as “modest bone augmentation” procedures, with no significant difference in infection risk compared to routine implant surgeries.

The exclusion criteria were as follows: (i) immunodeficiency; (ii) severe diabetes (HbA1c > 9%); (iii) serious systemic disease such as osteoporosis, hypertension, coronary atherosclerotic heart disease, acute myocardial infarction, heart failure, cerebrovascular diseases, hemophilia, COPD, asthma, IgA nephropathy, nephrotic syndrome, glomerulonephritis, chronic renal failure, epilepsy, dementia, Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, cancer and so on [23]; (iv) received radiation therapy to the head and neck; (v) acute or chronic oral infections (including ongoing periodontal infections); (vi) treated with antibiotics; (vii) allergic to penicillin; (viii) treated with bisphosphonates; (ix) needed implant surgeries requiring substantial bone augmentation. Substantial bone augmentation refers to complex bone augmentation surgeries that require a staged approach, such as onlay block grafting or free bone grafting (typically involving bone defects ≥ 5 mm or necessitating secondary surgeries for implant placement); (x) had a plan for immediate implant implantation (within 2 weeks); (xi) had parafunctional habits, such as bruxism, teeth clenching, and so on.

We checked the patients’ records of Changsha Stomatological Hospital, and patients eligible for inclusion in the system were divided into two groups:

•  Medication group: Patients were administered one 500 mg cefixime tablet and one 500 mg ornidazole tablet 0.5 h before implant surgeries.

• Non-medicated group: Patients were not administered any medicine before implant surgeries.

Table 1 shows the specifics of these patients.

Table 1.

Patient characteristics of the two groups

Variable	Medication group (n = 500)	Non-medicated group (n = 500)	Overall (n = 1000)
Gender
Male	262 (52.4%)	253(50.6%)	515(51.5%)
Female	238(47.6%)	247(49.4%)	485(48.5%)
Age (mean years ± SD)	61.3 ± 15.1	61.6 ± 14.7	61.5 ± 14.9
Smoking
Yes	140(28.0%)	121(24.2%)	261(26.1%)
No	330(66.0%)	352(70.4%)	682(68.2%)
Unknown	30(6.0%)	27(5.4%)	57(5.7%)
Jaw receiving implants
Mandible	190(38.0%)	202(40.4%)	392(39.2%)
Maxilla	293(58.6%)	277(55.4%)	570(57.0%)
Both	17(3.4%)	21(4.2%)	38(3.8%)
Implant system
Straumann	335(67.0%)	322(64.4%)	657(65.7%)
Astra	158(31.6%)	175(35.0%)	333(33.3%)
Nobel	7(1.4%)	3(0.6%)	10(1.0%)
Number of implants
1	270(54.0%)	208(41.6%)	478(47.8%)
2–3	190(38.0%)	215(43.0%)	405(40.5%)
≥ 4	40(8.0%)	77(15.4%)	117(11.7%)
Sinus elevation surgery	27(5.4%)	28(5.6%)	55(5.5%)
Implant placement and GBR surgery	25(5.0%)	23(4.6%)	48(4.8%)

Clinical procedures

We used three implant systems that are widely used in China: Nobel Biocare^®, Sweden; Astra Tech Dental Implant Systems^®, Dentsply Sirona, Sweden; and Straumann^® SLA, Straumann Implants, Switzerland. The implant system was selected for each patient by an experienced prosthodontist, and surgeons strictly followed a variety of surgical routines. Each patient had one or more implants in the mandible or maxilla, and durations of implant surgeries were noted. The necessity of adjunctive surgical procedures (e.g.: modest bone augmentation, GBR, maxillary sinus elevation) is determined in accordance with the clinical guidelines established by ITI (International Team for Implantology). Bone augmentation mentioned above was restricted to only collecting autogenous bone slices and bone pieces close to the actual operative site and placing implants simultaneously. According to their respective surgical protocols and routine procedures, surgeons prescribed 0.2% chlorhexidine before and/or after surgeries.

To ensure the implants’ successful osseointegration and long-term stability, implants were placed three months after tooth extraction, and early implants were placed one to two months after tooth extraction. We installed prosthetic restorations 4 months after the maxillary surgery or 3 months after the mandibular surgery. All patients received full-ceramic crown prosthetic restorations, which were cemented in vitro and subsequently secured with screws. All patients used bone-level implants. Occlusal evaluations were conducted at 3, 6, 9, and 12 months after surgeries to rule out occlusal trauma. Surgeons provided patients with oral hygiene instructions according to the evaluation results. None of the patients exhibited bruxism or teeth clenching. Thus, occlusal guards were not used. These surgical procedures used aseptic techniques to prevent microorganisms from contacting the surgical area directly or indirectly.

Patients were not routinely administered antibiotics after surgeries. Antibiotics were only prescribed in cases of definitive postoperative infection symptoms, like abscess, persistent redness, and swelling. Patients were examined and recorded 7–14 days (first follow-up) and 3–6 months (second follow-up) after implant surgeries.

Outcome variables

The primary outcome variable was implant failure, characterized as implant detachment or complete loss during follow-ups, implant mobility (clinical mobility > 1 mm) detected by surgeons when manually tightening abutments at the second follow-up (3–6 months after surgeries), or complications requiring clinical intervention occurred, including peri-implant bone resorption exceeding acceptable levels. Secondary outcome variables were postoperative infection and adverse events. Postoperative infection includes peri-implant mucositis and peri-implantitis. Any indication of bacterial infection, like surgical wound dehiscence or swelling, formation of fistula or abscess, persistent redness and swelling for more than 14 days and requiring antibiotic treatments, was considered as a postoperative infection. Adverse events include intraoperative complications like mucosal perforation and bleeding, and postoperative complications like gastrointestinal reaction (e.g.: nausea, vomiting, diarrhea), neurological reaction (e.g.: dizziness, hypersomnia, headache), and other reactions (e.g.: fever, urticaria). These outcome variables were recorded in detail at follow-up visits by trained technicians at Changsha Stomatological Hospital.

Data analyses

The differences in outcome variables between the two groups were expressed as 95% confidence intervals and relative risks. We used Pearson’s chi-square test (χ2) and Fisher’s exact test to examine the proportionate differences between the two groups. In the multiple logistic regression model, postoperative infection was the dependent variable. Smoking status (yes/no), diabetic status, age, implant system, number of implants (1, 2–3, and ≥ 4), sinus elevation surgery, implant placement and GBR surgery, and treatment group (medication/non-medicated) were used as independent variables. All analyses were performed with STATA 15 SE. Statistical significance was defined as 95% confidence intervals of relative risk or odds ratio values excluding one or P values less than 0.05.

Results

The study cohort included the medication and non-medicated groups, both containing 500 patients. As shown in Table 2, the two groups did not differ significantly in implant failure and postoperative infection (p > 0.05). On the other hand, there is a statistically significant increase in adverse events in the medication group (p < 0.001).

Table 2.

Major outcome variables of the two groups

Outcome	Medication group (n = 500)	Non-medicated group (n = 500)	RR(relative risk) (95% CI)	p value
Primary outcome
implant failure	4	3	1.333(0.300–5.930)	0.898
Secondary outcome
postoperative infection	23	25	0.920(0.528–1.599)	0.995
adverse events	111	21	5.286(3.294–8.493)	< 0.001

Table 3 shows specific adverse events that happened in the two study groups. The medication group showed a statistically significant increase in gastrointestinal and neurological adverse events, like nausea, vomiting, hypersomnia, dizziness, and diarrhea (p < 0.001). There was no significant difference in the risk of fever between the medication and non-medicated groups (p > 0.05). These results emphasized the need for monitoring these specific adverse effects in patients experiencing implant surgeries.

Table 3.

Major adverse events of the two groups

Outcome	Medication group (n = 500)	Non-medicated group (n = 500)	RR (95% CI)	p value
fever	7	9	0.778(0.292, 2.073)	0.714
nausea	33	2	16.500(3.907–69.183)	< 0.001
vomiting	15	1	15.000(1.956-114.883)	< 0.001
hypersomnia	19	3	6.333(1.773–22.727)	< 0.001
dizziness	28	5	5.600(2.020-15.428)	< 0.001
diarrhea	9	1	9.000(1.238–65.329)	< 0.001

Figure 1 compares rates of major outcomes and adverse events between the two groups.

Fig. 1.

Comparison of main outcomes’ and adverse events’ rates between the two groups. There was no significant difference in the implant failure, postoperative infection, and fever rates between the two groups (p > 0.05). The incidence rate of nausea, vomiting, hypersomnia, dizziness, and diarrhea increased significantly in the medication group

Subgroup analyses were needed to study the influence of multiple variables and control confounding factors. A multivariate logistic regression analysis of postoperative infection is shown in Table 4. Across all the subgroups analyzed, no variable was significantly associated with postoperative infection.

Table 4.

Multivariate analysis of postoperative infection between the two groups

Variable	OR(odds ratio) value	95% CI
Smoking
No	Ref
Yes	1.080	0.570–2.046
Diabetic status
without diabetes	Ref
well-controlled diabetes	1.500	0.675–3.287
Age (years)
<50	Ref
50–64	1.026	0.467–2.257
≥65	1.195	0.517–2.758
Implant system
Straumann	Ref
Astra	1.124	0.610–2.069
Nobel	2.322	0.283–18.984
Number of implants
1	Ref
2–3	0.991	0.546–1.797
≥4	0.315	0.073–1.349
Sinus elevation surgery
No	Ref
Yes	1.154	0.347–3.835
Implant placement and GBR surgery
No	Ref
Yes	0.856	0.201–3.635
Treatment group
Medication	Ref
Non-medicated	1.091	0.611–1.948

Discussion

Bacteria-associated infections impose significant economic and healthcare burdens [24]. In recent years, prophylactic antibiotics have become a standard practice in many medical procedures in China, including implant surgery, with the primary goal of preventing postoperative infections and implant failure [13, 22, 25]. Several studies have examined the efficacy of antibiotic use in dental implant surgeries. For instance, antibiotics such as cefazolin, clindamycin, and amoxicillin are typically used as prophylactic treatments in order to combat common pathogens like Staphylococcus aureus and Streptococcus pneumoniae, which always cause infections around the implant site. There are different academic opinions on preventing implant failure. Some studies suggest that antibiotics may reduce the risk of infection and implant failure. In contrast, others indicate their benefits might be minimal [26], especially in healthy patients with no pre-existing infections.

The most important concern with the overuse of antibiotics is the potential for antibiotic resistance [27–29]. Antibiotic resistance is a global issue and potentially leads to implant failure and poses a serious threat to human health. There are currently no corresponding clinical guidelines related to antibiotic prophylaxis in dental surgeries in China, even though other countries prescribe different antibiotic regimens and types for implant surgeries due to higher levels of antibiotic-resistant bacteria [30]. To reduce the risk of antibiotic resistance, investigating the need for antibiotic use before implant procedures is crucial, and the research results will give doctors more information and references to use while writing prescriptions.

Our study revealed that antibiotic prophylaxis did not significantly lower the chance of implant failure or postoperative infection. Since implant success is the primary concern in surgical settings, prophylactic antibiotic treatment may not be essential. According to the multivariate logistic regression analysis showed in Table 4, sinus elevation surgery (OR = 1.154, 95% CI = 0.347–3.835), implant placement and GBR surgery (OR = 0.856, 95% CI = 0.201–3.635) were not significantly associated with postoperative infection. The inclusion of these mild complex surgeries was to simulate real-world clinical scenarios rather than including high-risk cases, and the confounding effect of these procedures on infection and implant failure outcomes was excluded through the multivariate logistic regression analysis. As for the patient selection, it is worth mentioning that serious systemic diseases may affect implant surgeries. For example, patients with osteoporosis may experience aggravated alveolar bone resorption, which may affect the stability of implants. Cardiovascular diseases such as hypertension, coronary atherosclerotic heart disease, acute myocardial infarction, heart failure, and cerebrovascular diseases may increase the risk of bleeding and hematoma during implant surgeries and jeopardize osseointegration of the implant. Patients with hemophilia are prone to uncontrollable bleeding. Patients with respiratory diseases such as COPD and asthma may experience airway obstruction during surgeries, leading to dyspnea. Severe urinary system diseases such as IgA nephropathy, nephrotic syndrome, glomerulonephritis, and chronic renal failure may lead to infection, hyperkalemia, and abnormal bone metabolism. These diseases may interfere with the osseointegration process of implants and increase the surgical risk. Patients with neuropsychiatric disorders such as epilepsy, dementia, Parkinson’s disease, Alzheimer’s disease, and Huntington’s disease may have an increased surgical risk due to convulsions or difficulty in understanding and following medical advice. High-dose radiotherapy for patients with head and neck cancer can damage the osseointegration of implants. In addition, chemotherapy may affect bone metabolism and increase the risk of implant surgeries. Therefore, patients with serious systemic diseases were not included in the study.

The primary reason for the non-significant impact on implant failure is that infection is not the primary cause of implant failure; other factors, such as poor bone quality, implant design, surgical technique, and patient factors (e.g.: severe diabetes), are often more significant contributors to it. The second reason is related to the biofilms on the surface of implants. Bacteria may form biofilms, which could be particularly resistant to prophylactic antibiotics. Sharma highlighted the limitations of antibiotics in combating biofilm-related infections [31]. In recent years, a number of technologies and materials have emerged to reduce infection risks. For example, implants coated with antimicrobial agents or bioactive substances may inhibit bacterial adhesion and biofilm formation [31]. Photodynamic therapy, which uses light-activated compounds to target and destroy bacteria, has shown potential as a non-invasive treatment [32]. Additionally, using probiotics to modulate the oral microbiome is an innovative approach to reducing pathogenic bacterial colonization [33]. As for previous literatures utilizing other antibiotics before implant surgeries, there are different opinions. In Momand’s study, using amoxicillin before implant surgeries shows minimal benefits in reducing the incidence of implant failure and postoperative infection [22]. However, Roca-Millan’s study shows that in healthy patients, a single antibiotic prophylaxis dose (using amoxicillin or clindamycin) is indicated to prevent early implant failure [28]. Therefore, the impact of preoperative antibiotic use on the success of implant surgery remains undetermined, and our study will further fill this gap.

The medication group showed a significantly higher occurrence of adverse events, which further argues against the routine use of antibiotics before dental surgeries in China, as the potential harm to patients may outweigh the minimal benefits observed in preventing implant failure. Hospitals and clinicians should balance risks and benefits when formulating strategies for prophylactic antibiotic use in surgical procedures. The concurrent use of cefixime and ornidazole can cause various side effects. Specifically, gastrointestinal side effects are among the most frequently reported adverse reactions, including nausea, vomiting, diarrhea, abdominal pain, indigestion, and flatulence, as ornidazole and cefixime can both cause irritation and alterations in gut flora [34, 35]. Neurological side effects are also common with this combination. Patients may experience headache, dizziness, hypersomnia, and even seizures attributed to central nervous system effects of ornidazole [36]. The body’s immune system may react to the presence of the medications, leading to an increase in body temperature and fever. These side effects can negatively impact patient compliance and satisfaction, potentially undermining the overall success of implant treatment. Notably, other countries often use amoxicillin or clindamycin for antibiotic prophylaxis in implant surgeries. These drugs may have differences in the types and severity of adverse effects. Therefore, further studies comparing different antibiotic regimens are warranted.

Consequently, vigilant monitoring and patient education regarding the potential side effects of antibiotic therapy are needed [37, 38]. The financial burden of antibiotic prescriptions, coupled with the lack of significant clinical benefits, suggests that resources may be better allocated to other safer and more sustainable aspects of patient care, such as improved surgical techniques, enhanced aseptic protocols, postoperative monitoring, and patient education on oral hygiene practices [26]. Antibiotics should be prescribed only for patients at greater risk of infection, such as immunocompromised individuals, patients with systemic diseases, or patients undergoing complex implant procedures. Moreover, patients with systemic diseases should not have implant surgeries if they are not controlled.

There are some limitations of the study. First, the retrospective design may introduce selection bias. This study may not represent the general population in need of implant surgeries, as patient data were drawn from historical records rather than randomized cohorts. The study population was mostly made up of healthy or relatively healthy people, which limited the findings’ applicability to high-risk populations such as those with weakened immunity, severe underlying diseases, or those have undergone complex surgeries (such as complex bone augmentation surgeries). Second, the retrospective design may introduce information bias. The reliance on patients’ medical records could lead to incomplete or inaccurate documentation of certain variables like detailed smoking history and oral hygiene habits. Third, patients were gathered by different surgeons, which may have led to discrepancies in the standards for diagnosis and prescription. Fourth, wide confidence intervals in certain subgroups indicated potential variability due to small sample sizes. Thereby, larger sample sizes and stratified prospective investigations are required in the future to validate our results and detect additional possible effects of antibiotic use before dental surgeries. What is more, our study was lack of microbiological confirmation. No pathogen detection was conducted on infected patients, making it difficult to verify the effect of antibiotics on specific bacterial flora. In summary, future studies should concentrate on prospective, randomized controlled trials with larger sample sizes and more extended follow-up periods. We need to unify the operational standards of surgeons participating in the study, conduct unified preoperative training within Changsha Stomatological Hospital, and ensure the consistency of surgical operations. Moreover, future studies should explore the impact of more patient-related factors, such as comorbidities and lifestyle behaviors, to reduce confounding bias. We need to conduct a more detailed subgroup analysis and consider the influence of other variables such as implant site characteristics. We could focus on measures of patient-reported outcomes, such as satisfaction and quality of life, since they would provide a more comprehensive assessment of the risks and benefits of antibiotic use.

From a macro perspective, national dental associations should develop and enforce guidelines to limit antibiotic prophylaxis [39]. Clinicians, researchers, and policymakers must work together to develop evidence-based recommendations of antibiotics use in diverse clinical settings [40]. Public awareness initiatives can also inform patients about the dangers of excessive antibiotic use and the need for alternate prophylactic measures [41].

In summary, our findings challenge the routine use of cefixime and ornidazole before implant surgeries in China. For healthy patients with ASA grades I-II, the preoperative use of ornidazole combined with cefixime did not reduce the risk of implant failure or postoperative infection, but significantly increased gastrointestinal and neurological adverse events. Therefore, in clinical practice, prophylactic ornidazole and cefixime use before implant surgeries should be reconsidered. This study advocates for clinical evidence-based antibiotic stewardship to reduce unnecessary adverse events and antibiotic resistance, and provides evidence support for formulating localized guidelines. Further large-scale, multi-center studies with extended follow-up durations are required to refine clinical guidelines and ensure the judicious use of antibiotics in China [42]. Future research should explore the role of emerging technologies and materials in improving the implant success rate, for instance, probiotics and other microbiome-modulating therapies could contribute to infection prevention and then increase the implant success rate [43].

Conclusions

In conclusion, the use of cefixime and ornidazole before implant surgeries does not lower the incidence of implant failure or postoperative infection in healthy individuals. Moreover, gastrointestinal and neurological adverse events, including nausea, vomiting, hypersomnia, dizziness, and diarrhea, increased significantly in the medication group. Therefore, cefixime and ornidazole before implant surgeries may not be necessary to prevent bacterial infection and increase the implant success rate.

The findings of our study can guide clinical decision-making in China. To make better clinical decisions, clinicians should carry out the risk-benefit evaluation of administering antibiotics like cefixime and ornidazole. They should only use cefixime and ornidazole before implant surgeries for high-risk patients or complex surgeries.

Abbreviations

GBR

Guided bone regeneration

ITI

International Team for Implantology

OR

Odds ratio

RR

Relative risk

Authors’ contributions

AL collected and interpreted the patient data. AL and HP have drafted the work and substantively revised it. JZ provided technical support for the manuscript. XZ provided suggestions for revisions to the manuscript. ML directed the writing of the manuscript. All authors read and approved the final manuscript.

Funding

This work was supported by the Changsha Natural Science Foundation Project [grant number: kq2502309], the Undergraduate Research and Innovation Fund Program of Hunan University of Chinese Medicine [grant number:2024BKS034]; and the General Project of University and College Joint Fund of Hunan University of Chinese Medicine [grant number: 2024XYLH298].

Data availability

The datasets generated and analyzed during the current study are not publicly available due to the privacy policy of Changsha Stomatological Hospital, but are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

This study was approved by Medical ethics committee of Changsha Stomatological Hospital. The ethics approval number was (2023) Ethical review [research] No.98, and the date of approval was November 7th, 2023. Since the study did not involve direct intervention to patients, the ethics committee waived prospective informed consent and only required the anonymization of the data (such as removing identifiers like names and hospitalization numbers).

Consent for publication

All clinical data of patients were derived from the hospital’s routine diagnosis and treatment records and have passed ethical review before publication. No additional written consent is required, which complies with the ethical requirements of the Declaration of Helsinki regarding retrospective studies.

Competing interests

The authors declare no competing interests.