INTRODUCTION
The maxillofacial region, encompassing the jaw, face, and surrounding structures, is highly susceptible to injuries, particularly from road accidents. Treating these injuries is challenging as it requires restoring function while maintaining facial symmetry and aesthetics [1]. Functional correction ensures proper jaw alignment for essential activities, such as eating and speaking, while facial aesthetics significantly impact self-esteem and social interactions. Treatment must strike a balance between these two aspects for optimal outcomes. Achieving the best possible functional and aesthetic outcomes necessitates a collaborative approach involving surgeons, dentists, and various other specialists from different disciplines. Treatment plans should address bone healing, soft tissue repair, dental restoration, and facial symmetry to enhance the patient’s well-being [2]. Early intervention, particularly in young patients, is crucial for proper maxillofacial development, thereby preventing complications such as malocclusion, asymmetry, and impaired dental function. Management options may involve surgical procedures such as open reduction and internal fixation (ORIF), dental rehabilitation, soft tissue repair, and orthodontic management. Coordination among multiple specialties ensures holistic care and leads to improved overall outcomes. Early treatment of maxillofacial and dentoalveolar injuries minimizes the long-term impact on oral health, function, and aesthetics. Around 50% of maxillofacial injuries involve mandibular fractures, with mid-face and dentoalveolar fractures accounting for 33% and 5%, respectively [3]. Traumatic dental injuries (TDI) commonly affect maxillary central incisors (90%), with enamel/dentin fractures without pulp at 62% and luxation injuries at 50% [4]. Following fracture healing and removal of maxillomandibular fixation, dental rehabilitation, including root-analogue implants, restores stability and replaces lost teeth.
Post-healing dental rehabilitation provides a stable foundation for implants and prosthetics, ensuring long-term restoration of function, aesthetics, and oral health. In 1989, Lazzara [5] introduced the concept of immediate implant placement, which involves placing dental implants directly into the extraction socket immediately following tooth removal. This approach reduces overall treatment duration by removing the need for an additional surgical procedure and healing period, thereby streamlining the restoration process. Immediate implant placement preserves bone and soft tissue by filling the extraction site, thereby preventing bone loss and maintaining the natural gum contours. This protocol supports better aesthetics and implant stability [6]. Our study integrates immediate implant placement into the ORIF procedure for maxillofacial fractures, defining it as Total Maxillofacial Trauma Management. In adopting this approach, we also incorporated the principle of the regional acceleratory phenomenon (RAP) to enable simultaneous and comprehensive trauma care. This unified strategy is expected to reduce hospital stays, enable complete surgical intervention in a single operative session, and minimize patient exposure to anesthesia, antibiotics, and analgesics to a single instance.
We designed our study to assess whether immediate dental implant placement during ORIF results in better clinical outcomes compared to delayed implant placement after definitive fracture management.
METHODS
Study design and ethical clearance
A prospective study was conducted at a tertiary care institute between February 2022 and March 2024, following approval from the Institutional Ethics Committee (ECR/262/Inst/UP/3/RR-19).
Settings and consent
All oral and maxillofacial trauma patients presenting to the tertiary care unit were evaluated after primary stabilization. Patient recruitment was conducted in accordance with the established eligibility criteria. The study adhered to the principles of the Declaration of Helsinki, and written informed consent was obtained from all participants.
Hypothesis
Immediate implant placement during ORIF results in better clinical outcomes compared to delayed implant placement after the definitive fracture management.
Eligibility criteria
This study included patients aged 18 to 60 years who presented with maxillofacial trauma involving non-restorable fractured, avulsed, or missing teeth requiring ORIF. Patients with conditions that may interfere with accurate outcome assessment (such as cognitive impairment), pregnant patients, those classified as American Society of Anesthesiologists physical status III–IV, individuals with restricted mouth opening, and those unwilling to participate were excluded from the study.
Sample size estimation
The sample size of 36 patients was calculated based on the cumulative survival rate in two treatment groups using the formula:
The cumulative survival rates were p1=0.9325 (93.25%) for the immediate implant group and p2=0.9485 (94.85%) for the delayed implant group, with a clinically significant risk ratio e= 0.2. Considering a type I error (α) of 5% and a type II error (β) of 10% with a study power of 90%, the minimum sample size estimated was 18 for each group.
Methodology
All patients presenting with oral and maxillofacial trauma who fulfilled the eligibility criteria were randomized into two groups using Randomisation Allocation Software 2.0 to ensure a balanced allocation. The randomization codes were placed in sequentially numbered, opaque, sealed envelopes. At the time of enrolment, the next envelope in sequence was opened to assign the patient to a group. To minimize selection bias, the generation of the random sequence, preparation of envelopes, and allocation procedures were performed by individuals independent of the trial and not involved in patient recruitment, treatment, or assessment. As both the patients and treating surgeons were inherently aware of the allocated intervention, due to the nature of the study, complete blinding was not feasible. Nevertheless, outcome assessment was performed by an independent evaluator who remained blinded to group allocation, thereby maintaining partial blinding within the study. The patient’s demographic details, presenting symptoms, and clinical and radiological assessments, including an orthopantomogram, were recorded. Following this, they were randomly assigned to one of two groups (Fig. 1). Group 1 received definitive management of maxillofacial bony trauma, followed by root-analogue implant rehabilitation 6 months later, representing the delayed implant patient (DIP) (Fig. 2). In contrast, Group 2 underwent ORIF with simultaneous placement of a root-analogue implant, constituting the immediate implant patient (IIP) (Fig. 3).
Follow-up schedule
The follow-up schedule for patient assessment included both clinical and radiographic evaluations at specific intervals. The first follow-up took place on the first day, encompassing both clinical and radiographic assessments. The second follow-up was conducted on the seventh day, followed by the third follow-up on the 28th day, both of which focused solely on clinical assessment. The fourth follow-up was conducted at the end of the third month, incorporating both clinical and radiographic evaluations. The fifth and final follow-up was conducted at the end of the sixth month, assessing both parameters again.
Data collection and assessment
Patient assessment was carried out based on three key clinical parameters: pain, swelling, and stability. Patient satisfaction and radiological evaluation were further evaluated and documented.
1. Assessment of pain was conducted using the visual analogue scale (VAS), which ranged from 0 to 10, providing a subjective measure of pain intensity.
2. Swelling was assessed using the tape-measuring method, which measured postoperative facial swelling by calculating the distances from the outer canthus of the eye to the angle of the mandible (ab), and from the tragus of the ear to the corner of the mouth (cd).
3. Stability was determined through resonance frequency analysis (RFA) using the Osstell Mentor system (Osstell AB). It is based on implant stability quotient (ISQ) values: An ISQ value greater than 70 indicates high implant stability, values between 60 and 70 reflect moderate stability, while values below 60 suggest low stability. RFA operates on the principle that when an audible-range frequency is applied to an implant, the bone-implant interface influences the resonance frequency. A stronger bone-implant connection results in a higher resonance frequency, indicating greater stability. This comprehensive assessment ensures accurate monitoring of the implant’s clinical progress over time.
4. Patient satisfaction: patient satisfaction was categorized as favorable (3), acceptable (2), or suboptimal (1) based on their feedback and graded accordingly.
5. Radiographic assessment: crestal bone loss was measured using orthopantomograms at baseline, 3 months, and 6 months. The assessment was performed by calculating the difference between the actual implant length and the distance from the adjacent alveolar crest to the implant collar using ImageJ software. The actual bone loss was determined using the formula: y=ax÷b (y=Actual crestal bone loss, a=Crestal bone loss measured on X-ray, x=Actual implant length, b=Implant length on X-ray).
Outcomes assessed
The primary outcome was to evaluate implant stability among immediate and delayed implant post-ORIF. Secondary outcomes included the assessment of marginal/crestal bone loss around the implants and the evaluation of patient-related outcomes such as pain, swelling and patient satisfaction.
Statistical analysis
Statistical analysis was performed using Jamovi software and Stata version 17.0. Descriptive statistics were calculated for demographic variables, and group comparisons for age and sex were conducted using independent t-tests and chi-square tests, respectively. The results revealed no statistically significant differences between the two groups. The Mann-Whitney U test was used to compare VAS pain scores between groups over time. Swelling measurements, including canthal and tragus distances, were analyzed using independent t-tests. Implant stability and patient satisfaction scores were also evaluated using the Mann-Whitney U test, while changes in crestal bone levels were evaluated with independent t-tests. To adjust for potential confounders, multivariate regression analyses were performed. Linear regression was used for continuous outcomes (VAS pain, swelling, and ISQ), and ordinal logistic regression was used for patient satisfaction, with group as the primary predictor and age and sex as covariates. Regression coefficients (β), 95% confidence intervals, and p-values were reported, with significance set at p<0.05.
RESULTS
Clinical outcomes
A total of 36 patients were evaluated, with 18 in each group. The age comparison and sex distribution between the DIP and IIP groups showed no significant difference between the two groups (Table 1). Implant stability showed no significant difference on the first day but was significantly higher in the IIP group at the third and sixth months (p<0.001) (Table 2). Crestal bone loss revealed no significant differences among the groups at any time point (p>0.05) (Table 3). Pain evaluation using the VAS score revealed significant differences between the groups on the first day (p<0.001), the seventh day (p<0.001), and the 28th day (p<0.001). However, no significant differences were found at the third and sixth months (p=0.462, p=0.584, respectively) (Table 4). Significant differences in swelling were observed at the third and sixth months (p=0.009), with the IIP group exhibiting lower swelling. No significant differences were found on the first and seventh days (Table 5). Swelling was significantly higher in the IIP group on the first and seventh days (p<0.001). However, no significant differences were observed from the 28th day onward (Table 6). Satisfaction was initially higher in the DIP group on the first day (p=0.047), but by the third month, the IIP group had higher satisfaction (p<0.001). By the sixth month, both groups showed similar satisfaction levels (Table 7).
Multivariate analysis of postoperative outcomes
After adjustment for age and sex, only group assignment significantly predicted postoperative pain across all time points. The immediate-implant group experienced higher pain scores on day 1 (β=3.49; 95% CI 2.30–4.68; p<0.001), day 7 (β=2.22; p<0.001), and day 28 (β=1.95; p<0.001), but differences were no longer significant at 3 and 6 months (p>0.17). These results indicate greater short-term discomfort with immediate placement, but convergence of pain scores by 3 months. Swelling measured along the cantho-angle line showed no group difference early on (p>0.05), but by day 28, a trend toward less edema in the immediate group emerged (β=−0.72; p=0.067), becoming significant at 3 months (β=−0.89; p=0.01) and persisting at 6 months (β=−0.87; p=0.02), consistent with reduced residual swelling. Along the tragal-commissure line, swelling was greater in the immediate group on day 1 (β=1.27; p<0.001) and day 7 (β=1.05; p<0.001), equalized by day 28 (p=0.65), and reversed (β=−0.38; p=0.12) by 3 months, reflecting transient initial edema that resolved faster in the immediate group. Implant stability (ISQ) was significantly higher in the immediate-implant group immediately after placement (β=5.34; 95% CI 3.47–7.21; p<0.001) and again at 6 months (β=2.68; 95% CI 1.15–4.20; p<0.001), with a nonsignificant difference at 3 months (p=0.18). Patient satisfaction showed no significant differences between groups (p=0.999), with uniformly high ratings reported once early symptoms subsided (Table 8).
DISCUSSION
Dental implants are widely popular among clinicians and patients for restoring lost teeth. Tooth loss resulting from maxillofacial injuries can occur due to accidents, trauma, or falls. In emergency cases, assessing head and neck injuries is crucial before proceeding with dental rehabilitation.
Dental implants act as tooth root analogues, anchoring prosthetic teeth in the jawbone and helping patients restore function and aesthetics. Dentoalveolar injuries may occur independently or in combination with maxillomandibular fractures. Traditionally, dental implants are placed after the bony trauma has healed, following ORIF. This study assessed whether performing dental rehabilitation concurrently with ORIF can eliminate the need for a subsequent surgery, enabling complete rehabilitation in a single procedure.
Age plays a key role in trauma-related injuries, as younger individuals are more commonly affected. Implant rehabilitation in younger patients presents challenges due to limited bone stock or ongoing skeletal growth. The causes of TDI vary by age and country. Studies by Zengin and Unal reported that TDI was most common in the second decade of life, predominantly affecting males [7,8]. The findings differ from our study, where the mean ages were 30.94 years and 29.17 years for the DIP and IIP groups, respectively (Table 1). However, the male predominance in our study was consistent with their findings. Similar results in terms of age and gender distribution were reported by de Lira et al. [9].
Hashem et al. [10] measured postoperative pain using the VAS and reported mild to moderate pain that gradually decreased over time, with peak pain occurring on the first postoperative day. The findings align with our findings in the DIP group. Atalay et al. [11] reported higher mean VAS comfort scores (85.07) in patients undergoing delayed implant rehabilitation for oral and maxillofacial defects following trauma and tumor resection. The findings were consistent with our study, showing a VAS pain score of 0.22 for delayed implant rehabilitation (Table 4). Similarly, Vajdi Mitra et al. [12] reported mean VAS pain scores of 2.00±1.15 on day three, 0.40±0.84 at 3 months, and 0.00± 0.00 at 6 months, which closely match our results (Table 4). Lim et al. [13] reported a mean VAS satisfaction score that was comparable to our pain score, while Obimakinde et al. [14] documented a mean VAS score of 2.9. However, there is currently no documented data on the use of immediate implants in cases of maxillofacial fractures.
Immediate postoperative swelling was greater in the IIP group compared to the delayed implant group (Tables 5, 6). The findings were on expected terms, as the IIP group underwent maxillofacial trauma treatment and implant placement simultaneously, leading to increased surgical trauma and swelling. However, by the third month, the resolution of swelling was faster in the IIP group compared to the DIP group, showing statistical significance (p=0.009) (Table 5). The result likely reflects the RAP, which enhances tissue healing following surgical trauma.
Schwartz-Arad and Levin [15]. reported postoperative swelling in 5.7% of delayed rehabilitation cases, which resolved within a week, similar to the findings of Mundt et al. [16]. However, our results contrast with those of Pal et al. [17], who documented no apparent swelling in the immediate implant groups, while the delayed implant group experienced swelling only after surgery. The result reflects that comprehensive management of maxillofacial trauma patients, along with dental rehabilitation, can be accomplished in the same setting. Alexandre et al. [18] reported more favorable patient- and clinician-related outcomes with immediate implant placement compared to delayed placement. However, there is currently no clinical evidence available regarding postoperative swelling in maxillofacial trauma patients receiving immediate implant placement simultaneously. Our findings demonstrate improved patient satisfaction and implant stability in later follow-ups. The findings are likely a result of the reduced number of additional surgical procedures. However, the immediate post-surgical outcome (pain, swelling) favored the delayed implant group because of the nature of the study. Clinically, RFA is used to assess implant stability immediately after placement and during follow-up, aiding in the evaluation of failure risk [19]. In our study, stability was significantly greater in the IIP group than in the DIP group (p<0.01) (Table 2). This finding is consistent with the RAP, which enhances metabolic activity in tissues after injury or surgical stress [20]. RAP accelerates tissue repair and remodeling by increasing cellular activity in both hard and soft tissues, leading to enhanced bone turnover through activation of basic multicellular units. In the alveolar bone, this response produces temporary woven bone that remodels into mature lamellar bone. Stimuli such as dental extraction, fracture, or surgery trigger RAP, enabling the bone to adapt to new mechanical demands and reduce microdamage [21]. The favorable outcomes of our study, including better implant stability and comparable (yet minimal) marginal bone loss in immediate implant placement during ORIF, support this mechanism. Granic et al. [19] reported mean ISQ values of 4.8 for IIP and 4.67 for DIP, which support our findings. However, Gehrke et al. [22] found that implants placed in healed bone had greater stability, contradicting our results, where the IIP group exhibited higher stability.
On evaluating the patient satisfaction, the DIP group initially reported higher satisfaction on the first day (p=0.047) and by the third month (p<0.001). However, by the sixth month, both groups demonstrated similar levels of satisfaction after implant placement. These findings align with the study by Pal et al. [17].
Crestal bone loss around successful dental implants typically ranges from 1 mm to 2.6 mm. Since the late 1980s, clinical recommendations have indicated that marginal bone loss should remain within 1.5 mm during the first year after implant loading, followed by a yearly loss of no more than 0.2 mm [23]. Atalay et al. [11] also emphasized that for an implant to be considered successful, marginal bone loss in the first year should not exceed 1.5 mm. Through our study, we reported a mean crestal bone loss of 0.06 mm in both groups, aligning with the established success criteria. Although some studies report lower rates, our findings are consistent with the majority of published research.
After adjusting for potential confounders, the multivariate regression analysis demonstrated that immediate implant placement increased short-term pain and swelling, while significantly enhancing implant stability and reducing late-phase oedema. All other covariates were clinically negligible. According to Cohen’s (1988) conventions, the magnitude of these adjusted differences ranged from moderate to large (approximately 0.5–0.9 SD units), indicating that the statistically significant findings are also clinically meaningful.
Given the scarcity of literature on dental implant rehabilitation in maxillofacial trauma patients, the present study provides preliminary yet encouraging evidence in favor of immediate implant placement during ORIF. Within the limitations of a small sample size and a relatively short follow-up period of 6 months, immediate implant placement demonstrated better implant stability and more favorable patient-reported outcomes, including reduced pain and swelling, compared with delayed placement. This approach also shortened overall treatment duration and reduced patient morbidity. Future long-term studies with larger cohorts are required to validate these findings before definitive clinical recommendations can be made.
The study’s strength lies in its holistic approach to comprehensive management of maxillofacial trauma patients, along with dental implant rehabilitation. Through its objective nature, the patient’s outcomes were assessed comprehensively while restoring form and function at the earliest. The study is not without limitations. The relatively small sample size (n=36) limits the generalizability of the findings, and the 6-month follow-up duration is insufficient to conclude long-term implant stability and peri-implant bone changes. A larger sample size and extended follow-up would provide deeper insights, particularly regarding crestal bone loss and long-term implant success.
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