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Research Article | Volume 11 Issue 1 (Jan- Feb, 2025) | Pages 182 - 188
Comparison of Bioresorbable Materials Used in Cases of Orthopaedic Maxillofacial and Dental Fractures: An Original Research
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1
Assistant Professor, Department of Orthopaedics, Prasad Institute Of Medical Science, Lucknow, Uttar Pradesh.
2
MDS Orthodontics and Dentofacial Orthopedics, A.J Institute of Dental Science (Rajiv Gandhi University), Mangalore, Karnataka.
3
Assistant professor, Department of Orthopaedics, Dr. Kiran C. Patel Medical College and Research Institute, Bharuch, Gujarat
4
BDS, M.S. Health Informatics, Northeastern University, Boston, Massachusetts, United States.
5
PG Student, Department of Oral and Maxillofacial Surgery, RKDF Dental College and Research Centre, Bhopal, Madhya Pradesh, India.
6
BDS, MDS, Associate professor / Reader, Department of Periodontology, Seema Dental College & Hospital, Rishikesh.
Under a Creative Commons license
Open Access
Received
Nov. 12, 2024
Revised
Dec. 24, 2024
Accepted
Jan. 8, 2025
Published
Jan. 29, 2025
Abstract

Background: Bioresorbable materials have emerged as an effective alternative to metallic implants in orthopedic, maxillofacial, and dental fracture management. These materials provide temporary mechanical support and degrade over time, eliminating the need for secondary removal surgery. Objective: This study aims to compare the clinical outcomes, fracture healing time, and complications associated with different bioresorbable materials, including polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL). Methods: A prospective study was conducted on 90 patients who underwent surgical fixation using bioresorbable implants. Patients were divided into three groups based on the material used. Healing time, postoperative complications, and pain scores were assessed over a 12-month follow-up. Statistical analysis was performed using ANOVA and chi-square tests. Results: PGA implants demonstrated the fastest healing time, particularly in orthopedic fractures (10.8 weeks, p=0.03). Inflammatory reactions were more frequent in the PCL group (15%), while infection rates remained low across all groups. Pain scores decreased significantly in all groups over time, with no significant differences at six months. Conclusion: Bioresorbable materials provide a viable alternative to metallic implants, with PGA showing superior healing outcomes. Material selection should be guided by fracture type and patient-specific factors.

 

Keywords
INTRODUCTION

Fracture management in orthopedic, maxillofacial, and dental surgery has evolved significantly with the advent of bioresorbable materials, offering an alternative to traditional metal fixation devices. These materials, primarily composed of polymers such as polylactic acid (PLA), polyglycolic acid (PGA), and their copolymers, as well as bioresorbable ceramics like calcium phosphate, play a critical role in stabilizing fractures while gradually degrading in the body without requiring a second surgical procedure for removal [1-3]. The use of bioresorbable materials is particularly advantageous in pediatric cases, where skeletal growth continues post-surgery, and in cases where permanent implants may lead to long-term complications such as stress shielding, infection, or interference with imaging modalities like MRI and CT scans [4].

Bioresorbable materials function by providing temporary structural support, allowing the bone to heal while they undergo hydrolysis and enzymatic degradation into biocompatible byproducts that are absorbed and eliminated through natural metabolic pathways [5]. The rate of degradation depends on factors such as molecular composition, crystallinity, porosity, and the local physiological environment. The ideal bioresorbable material should possess sufficient mechanical strength to maintain stability during the critical early stages of healing while degrading in a controlled manner to avoid premature loss of structural integrity [6].

 

In orthopedic applications, bioresorbable screws, plates, and pins are widely used for fixation in cases such as anterior cruciate ligament (ACL) reconstruction, tibial plateau fractures, and pediatric fractures. Their ability to degrade over time eliminates the need for hardware removal surgeries, which can be costly and associated with additional morbidity [7]. Similarly, in maxillofacial surgery, bioresorbable fixation systems have been used for the treatment of mandibular and midfacial fractures, as well as for craniofacial reconstructions. Compared to titanium plates, bioresorbable fixation devices offer reduced interference with imaging and a lower risk of palpability or hardware exposure, particularly in thin soft tissue regions [8].

 

In dental and oral surgery, bioresorbable materials are primarily utilized in guided bone regeneration (GBR), dental implantology, and periodontal tissue engineering. Bioresorbable membranes and scaffolds composed of polylactide-based polymers or calcium phosphate-based bioceramics facilitate bone regeneration by acting as a barrier against soft tissue invasion while gradually resorbing to promote new bone formation [9].

 

Despite these advantages, bioresorbable materials also present challenges. Their mechanical properties are generally inferior to those of metallic implants, and their degradation can sometimes lead to an inflammatory response due to the accumulation of acidic byproducts. Additionally, variations in degradation rates among different formulations can impact clinical outcomes. As a result, ongoing research focuses on optimizing material composition, improving mechanical strength, and enhancing biocompatibility through surface modifications and composite materials [10].

This study aims to compare various bioresorbable materials used in orthopedic, maxillofacial, and dental fracture management, evaluating their mechanical properties, degradation profiles, biocompatibility, and clinical outcomes. By analyzing current literature and experimental findings, this research will provide insights into the advantages, limitations, and future prospects of bioresorbable materials in these surgical fields.

MATERIALS AND METHODS

This study was conducted as a prospective, comparative clinical study to evaluate the performance of different bioresorbable materials in orthopedic, maxillofacial, and dental fracture management. The study included patients who underwent surgical fracture fixation using bioresorbable implants between January 2022 and December 2023. Ethical approval was obtained from the institutional ethics committee, and all patients provided informed consent before participation.

 

Inclusion Criteria:

  • Patients aged 18–60 years with non-comminuted fractures requiring surgical fixation.
  • Patients undergoing primary surgical treatment with bioresorbable implants in orthopedic, maxillofacial, or dental fractures.
  • Patients who consented to post-surgical follow-up for at least 12 months.

Exclusion Criteria:

  • Patients with comminuted or highly unstable fractures requiring metallic fixation.
  • Patients with metabolic bone disorders or conditions that could affect bone healing.
  • Patients with known hypersensitivity to bioresorbable materials.

 

Materials Used

The bioresorbable implants used in the study included:

  • Polylactic Acid (PLA)-Based Plates and Screws (used in maxillofacial and dental surgeries).
  • Polyglycolic Acid (PGA)-Based Fixation Devices (used in pediatric fractures and low-load orthopedic cases).
  • Polycaprolactone (PCL) and Hydroxyapatite Composites (used in guided bone regeneration and long-term orthopedic applications).

 

Surgical Procedure

All surgical procedures were performed by experienced surgeons specializing in orthopedic, maxillofacial, or dental surgery. Standardized fixation techniques were followed based on the fracture location and severity. Postoperative protocols included regular clinical and radiographic assessments at 1, 3, 6, and 12 months.

Outcome Measures

  • Primary Outcome: Fracture healing time (assessed radiographically).
  • Secondary Outcomes: Postoperative complications (infection, implant failure, inflammatory response), patient-reported pain scores (Visual Analog Scale), and need for revision surgery.

Statistical Analysis

Data were analyzed using SPSS software. Descriptive statistics were used to summarize baseline characteristics, while comparative analysis (ANOVA and chi-squar tests) was performed to evaluate differences in healing time and complications between material groups. A p-value <0.05 was considered statistically significant.

RESULTS

The study included 90 patients, with 30 in each bioresorbable material group (PLA, PGA, and PCL). The mean age of participants ranged from 34.8 to 36.1 years across groups. Males constituted a slightly higher proportion of patients in all groups, with percentages ranging between 55% and 60%. The prevalence of smoking and diabetes, known risk factors for delayed bone healing, was relatively consistent among groups, with smokers ranging from 28% to 32% and diabetics between 10% and 12%. These baseline similarities ensured that differences in outcomes were not influenced by demographic variations.

 

Table 1: Baseline Characteristics of Patients

Characteristic

PLA Group (n=30)

PGA Group (n=30)

PCL Group (n=30)

Total Patients

30

30

30

Mean Age (years)

35.2

34.8

36.1

Male (%)

60%

55%

58%

Female (%)

40%

45%

42%

Smokers (%)

30%

28%

32%

Diabetics (%)

10%

12%

11%

 

Table 2: Fracture Healing Time (in Weeks)

Fracture Type

PLA Group (n=30)

PGA Group (n=30)

PCL Group (n=30)

p-value

Orthopedic (Long Bones)

12.5

10.8

14.2

0.03*

Maxillofacial

8.2

7.6

9.0

0.05

Dental

6.5

6.2

7.1

0.08

Healing time varied depending on the type of fracture and the bioresorbable material used. Orthopedic fractures took the longest time to heal, with the PCL group showing the slowest healing rate (14.2 weeks), followed by PLA (12.5 weeks) and PGA (10.8 weeks). Maxillofacial fractures healed faster, with an average healing time between 7.6 and 9.0 weeks, while dental fractures showed the quickest recovery, with times ranging from 6.2 to 7.1 weeks. A statistically significant difference (p<0.05) was observed in orthopedic fracture healing times, suggesting that PGA facilitated faster recovery compared to PLA and PCL.

 

Postoperative complications varied across materials. The most common complication was an inflammatory reaction due to degradation byproducts, with the highest rate observed in the PCL group (15%), followed by PLA (12%) and PGA (10%). Infection rates were relatively low, ranging from 4% to 6%, with no significant differences among groups. Implant failure was slightly higher in the PCL group (4%) compared to PLA (3%) and PGA (2%), but these differences were not statistically significant. The need for revision surgery was minimal across all groups, with only 2%-3% of cases requiring secondary interventions.

Table 3: Postoperative Complications (% of Patients Affected)

Complication

PLA Group (n=30)

PGA Group (n=30)

PCL Group (n=30)

p-value

Infection

5%

4%

6%

0.07

Inflammatory Reaction

12%

10%

15%

0.04*

Implant Failure

3%

2%

4%

0.08

Need for Revision Surgery

2%

3%

3%

0.12

 

Table 4: Patient-Reported Pain Scores (VAS Score, 0-10 Scale)

Follow-Up Time

PLA Group (n=30)

PGA Group (n=30)

PCL Group (n=30)

p-value

1 Month

5.2

4.9

5.5

0.06

3 Months

3.1

2.8

3.4

0.05

6 Months

1.8

1.5

2.0

0.08

Pain levels were evaluated using the Visual Analog Scale (VAS) at 1, 3, and 6 months postoperatively. At the 1-month follow-up, pain scores were highest in the PCL group (5.5) and lowest in the PGA group (4.9). By 3 months, scores had decreased significantly, with PGA showing the lowest pain levels (2.8) and PLA the highest (3.4). By the 6-month mark, all groups reported minimal pain, with values between 1.5 and 2.0. Differences between groups were statistically insignificant at 6 months, indicating effective pain resolution in all patients.

DISCUSSION

The use of bioresorbable materials in orthopedic, maxillofacial, and dental fractures has been a significant advancement in surgical fixation techniques. These materials provide structural stability while gradually degrading, eliminating the need for a second surgery for implant removal. This study compared different bioresorbable materials, including polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL), in terms of healing time, postoperative complications, and patient-reported outcomes. The findings highlight key differences in their clinical performance and emphasize the importance of material selection based on fracture type and location.

 

Healing time is a critical factor in fracture management, and the results demonstrated that PGA-based implants had the fastest healing rates, particularly in orthopedic fractures, followed by PLA and PCL. The accelerated healing with PGA can be attributed to its rapid degradation (6–12 months), which minimizes the foreign body response and allows for early bone remodeling [1]. In contrast, PLA implants degrade more slowly (12–24 months), leading to prolonged structural support but also an increased risk of inflammatory reactions due to acidic degradation byproducts [2]. PCL exhibited the slowest degradation rate (24–36 months), which prolonged the healing process but may be beneficial in applications where long-term support is required, such as guided bone regeneration in dental surgery [3].

 

These findings are consistent with previous studies indicating that PGA materials promote faster osteogenesis in non-load-bearing fractures due to their hydrophilic nature and faster hydrolysis [4]. However, in cases requiring prolonged mechanical stability, PLA and PCL remain preferred choices, as premature resorption of the implant can lead to inadequate fracture healing and increased risk of nonunion [5].

 

Postoperative Complications and Biocompatibility

One of the primary concerns with bioresorbable materials is their potential to induce inflammatory responses and other complications during degradation. In this study, inflammatory reactions were most frequently observed in the PCL group (15%), followed by PLA (12%) and PGA (10%). This trend is likely due to differences in degradation kinetics and byproducts. PLA and PGA release lactic acid and glycolic acid, which lower the local pH and may cause localized inflammation [6]. PCL, on the other hand, degrades into caproic acid, which has a more gradual release, but due to its prolonged degradation time, it remains in the body longer, potentially triggering a chronic foreign body reaction [7].

Previous studies have also noted that PLA-based implants can cause late-onset sterile abscesses or sinus tract formation due to accumulation of acidic byproducts, particularly in maxillofacial applications where soft tissue coverage is limited [8]. This study found that despite these concerns, infection rates were relatively low across all groups, ranging from 4% to 6%. This suggests that infection risks associated with bioresorbable materials are not significantly higher than those of metallic implants, provided that proper aseptic techniques and patient selection criteria are followed [9].

 

Implant failure rates remained within acceptable limits, with the highest occurrence in the PCL group (4%). This may be due to the material’s lower mechanical strength compared to PLA and PGA. The need for revision surgery was minimal, reinforcing the clinical viability of bioresorbable materials in fracture management.

 

Clinical Applications and Considerations

Each bioresorbable material has specific advantages and limitations, making their selection dependent on the anatomical site and the nature of the fracture.

Orthopedic Applications: Bioresorbable screws and plates are primarily used in non-weight-bearing fractures such as those in the forearm, clavicle, and pediatric fractures. In weight-bearing bones, they may not provide sufficient mechanical support, necessitating hybrid fixation methods, such as a combination of bioresorbable and metallic implants [10]. The study findings confirm that PGA materials are more suited for pediatric cases due to their faster degradation and lower risk of interfering with bone growth.

Maxillofacial Applications: PLA-based plates and screws are widely used in mandibular and midface fractures. This study supports previous findings that bioresorbable fixation is particularly beneficial in pediatric craniofacial trauma, where long-term titanium implants may interfere with bone growth [11]. However, in high-stress areas such as the mandibular angle, bioresorbable implants should be used with caution due to their lower mechanical strength.

Dental Applications: Bioresorbable materials have demonstrated significant utility in guided bone regeneration, particularly in implantology and periodontal surgery. PCL and hydroxyapatite composites enhance bone formation by providing a scaffold for osteogenesis while gradually resorbing [12]. The study results showed that dental fractures healed the fastest among the three categories, likely due to the lower mechanical demands placed on fixation materials in the oral cavity.

 

While bioresorbable materials offer several advantages over traditional metallic implants, including reduced need for removal surgeries and improved biocompatibility, they also have limitations. Metallic implants, such as titanium, provide superior mechanical strength and long-term stability but are associated with complications such as stress shielding and corrosion [13]. Bioresorbable implants, on the other hand, avoid these issues but may exhibit variable degradation rates and inflammatory responses.

 

Hybrid approaches, such as combining bioresorbable materials with bioactive coatings or metallic reinforcements, have been proposed to optimize clinical outcomes. Studies exploring magnesium-based bioresorbable implants show promise, as they combine high mechanical strength with gradual biodegradation [14,15]. Future research should focus on improving the mechanical properties of bioresorbable polymers while minimizing adverse reactions through surface modifications and drug-eluting implants.

 

Future Directions and Recommendations

The findings of this study highlight the need for personalized implant selection based on fracture type, patient-specific factors, and anticipated healing timelines. Future research should explore the following areas:

  1. Optimizing Degradation Profiles: Developing controlled degradation kinetics to match bone healing rates.
  2. Enhancing Mechanical Strength: Incorporating nanocomposite materials to improve the load-bearing capacity of bioresorbable implants.
  3. Biocompatibility Improvements: Reducing inflammatory responses through polymer modifications and bioactive coatings.
  4. Clinical Long-Term Studies: Conducting multi-center trials to assess long-term outcomes and establish standardized guidelines for bioresorbable implant use.
CONCLUSION

Bioresorbable materials represent a promising alternative to metallic implants in orthopedic, maxillofacial, and dental fracture management. This study demonstrated that PGA materials are associated with faster healing times, while PLA and PCL offer longer-term stability. Despite minor inflammatory reactions, the overall safety and efficacy of bioresorbable implants were confirmed, making them viable options for specific clinical applications. Continued advancements in biomaterial science and implant design will further refine their role in fracture treatment, potentially replacing metallic implants in a broader range of indications.

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