Experience with Resorbable Plates for Fixation of Mandible Fracture. A Prospective Study of 10 Cases.

Aim: This study aims to evaluate the efficacy of resorbable plates for the fixation of mandible fracture. Materials and
Methods: 10 cases of fracture mandible were treated with resorbable plates using the Inion CPS system. Patients were evaluated during their entire hospital stay and recalled on 1st, 4th, and 8th postoperative weeks. A thorough evaluation was done at the recall visits for any surgical and postoperative complications such as infection, malocclusion, neural abnormalities, wound or suture dehiscence, segmental mobility, foreign body reaction, and pain on biting. Bite force measurements were taken to evaluate the return of function.
Results: Clinical union of the fracture was noted at the 8th week follow-up examination for all cases. There were swelling and pain at the operated site at 8th week follow-up for one patient, which was managed conservatively. The mean bite force was recorded for different regions and it increased over the entire follow-up period progressively.
Conclusion: These plates and screws are an essential tool in the treatment of mandibular fractures owing to benefits such as biodegradability, biocompatibility, and the ability to be eliminated via the body's natural processes. Copyright:

INTRODUCTION

The objectives of mandibular fracture care are to restore the preexisting anatomical structure, facial attractiveness, and functional occlusion. Internal fixation of mandibular fractures with plates and screws is already a recognized form of therapy, despite the fact that similar goals may be accomplished via closed reduction and intermaxillary fixation (IMF). The advantages of open reduction internal fixation include reduction or elimination of the postoperative IMF, better oral hygiene, nourishment, and phonetics. The functional restriction of the articulation due to disuse is also reduced.[1]

Bone healing should be supported, not interfere with imaging, and resorb after the healing process is complete. The use of metallic implants in the treatment of mandibular fractures has become widespread. Because they are not resorbable, they have a big drawback.[23]

To prevent the complications of metal fixation, such as the requirement for a second surgery to remove plates and screws, interference with radiological assessment, stress shielding, growth irregularities, and bone resorption that metal fixation might cause, bioresorbable devices have been enhanced.[45]

Metallic plates, on the other hand, can be perceptible, necessitating further surgery for removal. They have also been linked to radiologic interference, probable hardware migration, temperature sensitivity, osteolysis, corrosion, and peri-implant soft tissue reactions.[6]

The self-reinforced (SR) technology has developed to address these mechanical limitations. Resorbable plate-screw systems' metabolic end product is totally eliminated via the body's natural channels. Although these plates are effective in treating certain face fractures, notably those of the maxilla, further research is required for the treatment of mandible fractures.[7] The goal of this research is to determine if resorbable plates can effectively fixate mandibular fractures.

MATERIALS AND METHODS

Our institute's department of oral and maxillofacial surgery performed the research, which was a prospective study. To begin the study, the research and ethics commission had to approve it. For the research, the clinics screened patients with mandibular fractures who were present. Patients with mandibular fractures were chosen for the research after a clinical and radiological examination. The preanesthetic assessment was conducted after a thorough examination of the patient's medical and hematological status. After receiving the patient's agreement, he or she was enrolled in a clinical trial.

Inclusion criteria

Open reduction and internal fixation is necessary for patients who have a fracture of the mandibular body (symphysis, angle, or ramus) and need stability and repair

Patients who are willing to give informed consent.

Exclusion criteria

Patients with uncontrolled systemic disorders

Patients with cervical fractures

Comminuted/infected fractures.

RESULTS

Out of the total of 10 patients enrolled in our study, 8 were male and 2 were female patients. Age varied from 15 to 38 years old, with a mean of 28.1 years. The causes were motor vehicle accidents (50%), self-fall (30%), aggravated assaults (10%), and domestic violence (10%). There was a mean delay of 2.5 days for the initial presentation to our department following trauma. All fractures occurred in patients with complete dentitions. The most common site of fracture was the parasymphysis (n = 6, 54.5%), followed by symphysis (n = 2, 18.1%), body (n = 2, 18.1%), and angle (n = 1, 9.09%). The mean mouth opening was found to be 1.5 cm. Teeth in the line of fracture were present in 5 out of the 11 fractures sites treated. Only one tooth in the line of fracture was removed, during the 3rd month postoperatively. Preoperative IMF was done in 3 patients for an average of 2 days. Radiographic evaluation revealed 8 cases with displaced fractures and 2 with undisplaced fractures [Table 1].

Table 1

Follow up data

Case number	1st week postoperative					4th week postoperative
	Infection	Dehiscence	Nerve paraesthesia	Occlusion	Segmantal mobility	Infection	Dehiscence	Nerve paraesthesia	Occlusion	Segmantal mobility
1	Absent	Absent	Present	Unsatisfactory	Present	Absent	Absent	Present	Satisfactory	Present
2	Absent	Absent	Absent	Satisfactory	Present	Absent	Absent	Absent	Satisfactory	Absent
3	Absent	Absent	Absent	Unsatisfactory	Present	Absent	Absent	Absent	Satisfactory	Absent
4	Absent	Absent	Present	Satisfactory	Present	Absent	Absent	Present	Satisfactory	Absent
5	Absent	Absent	Absent	Unsatisfactory	Present	Absent	Absent	Absent	Satisfactory	Absent
6	Absent	Absent	Absent	Satisfactory	Present	Absent	Absent	Absent	Satisfactory	Absent
7	Absent	Absent	Absent	Satisfactory	Absent	Absent	Absent	Absent	Satisfactory	Absent
8	Absent	Absent	Absent	Satisfactory	Absent	Absent	Absent	Absent	Satisfactory	Absent
9	Absent	Present	Absent	Satisfactory	Present	Absent	Absent	Absent	Satisfactory	Absent
10	Absent	Absent	Absent	Satisfactory	Present	Absent	Absent	Absent	Satisfactory	Absent
Case number		8th week postoperative
		Infection	Dehiscence		Nerve paraesthesia		Occlusion		Segmantal mobility
1		Absent	Absent		Absent		Satisfactory		Absent
2		Absent	Absent		Absent		Satisfactory		Absent
3		Absent	Absent		Absent		Satisfactory		Absent
4		Absent	Absent		Present		Satisfactory		Absent
5		Absent	Absent		Absent		Satisfactory		Absent
6		Absent	Absent		Absent		Satisfactory		Absent
7		Absent	Absent		Absent		Satisfactory		Absent
8		Absent	Absent		Absent		Satisfactory		Absent
9		Absent	Absent		Absent		Satisfactory		Absent
10		Absent	Absent		Absent		Satisfactory		Absent

Out of the 10 surgeries performed, 6 were done under general anesthesia and 4 were done under local anesthesia [Figure 1]. The mean duration of surgery was 1.4 h [Figure 2]. Out of the 44 screws placed, 2 screws (0.045%) broke during the procedure [Chart 1]. There was no plate breakage intraoperatively in any case. IMF postoperatively was placed in only 3 cases for a period from 3 to 10 days (mean 5.3 days).

Figure 1

Final plate adaptation

Figure 2

Intra-operative photograph

Chart 1

Complications

Clinical union of the fracture was noted at the 8th week follow-up examination for all cases. Occlusal stability was also achieved by the 8th week for all cases. None of the cases reported back with signs of infection. However, in one case, there was swelling and pain at the operated site at 8th week follow-up. The swelling subsided with the administration of antibiotics and anti-inflammatory drugs. Dehiscence was noticed in one patient postoperatively during the 1st week, which was resolved by local measures. None of the patients needed any revision surgery for the removal of the implants. One patient had mental nerve paresthesia for 4 months postoperatively [Chart 1]. As a consequence of this investigation, 100% of the bone healing was good. The 8-week follow-up detected palpable plates in all patients.

The mean bite force was recorded for different regions (right molar, a right canine, incisor, left canine, and left molar) and it increased over the entire follow-up period progressively [Chart 2].

Chart 2

Mean bite force across various sites

DISCUSSION

Ti-plated surfaces are vulnerable to hardware removal, which is one of their main flaws. Even though it is still contentious for asymptomatic patients, data on plate palpability, corrosion, carcinogenic potential, and other negative effects have encouraged writers to suggest screw and plate removal following fracture healing.[8] If you are looking for a system that does not have any of the drawbacks associated with a metal plate system, the bioresorbable system is the best option.[9]

According to a 1993 study published by Bergsma et al.,[10] patients first evaluated by Bos et al.[11] returned due of edema at the implantation site 3 years later. A biological response to polymer-induced chemical irritation is suggested by a late inflammatory response, which is dependent on the tolerance and clearance capability of local tissues.[12] At the 8-week follow-up in our trial, one patient developed edema and discomfort at the surgical site.

Degradation of Poly Glycolic Acid (PGA) occurs in 4–6 weeks after implantation, but Poly-L-Lactic Acid (PLLA) might take up to 5 years to degrade fully.[13] Due to their hydrophobic semicrystalline structure, PLLA breakdown is relatively slow. As a result of its extremely amorphous structure and strong hydrolytic activity, PGA degrades quickly.[14] Craniomaxillofacial implants made of PLLA and PGA are popular because of their desirable combination of strength and resorption qualities. Mechanical characteristics and degradation rates can be precisely regulated. The strength, malleability, and resorption profile of a polymer are all improved when trimethylene carbonate is included into its backbone.[15] Resorbable SR devices have had the most success in clinical trials.

There was no evidence of radiographic image scatter, distortion, or alteration in radiographic quality. Only the screw holes were visible on the radiographs [Figure 3].

Figure 3

Postoperative radiograph

It is possible to limit the risk of infection using antibiotics and resorbable plates. These devices are “multifunctional” in the sense that they are both fixation and osteoconductive.[16] Biodegradable implants are expensive, which probably limits their widespread use.[17]

CONCLUSION

Biodegradable materials have opened up a plethora of possibilities since their origin 40 years ago. Since the invention of polyglycolic acid suture, the research of bioabsorbable polymers as medicinal materials has developed significantly. Initial concerns about their biocompatibility and deterioration have faded after significant investigation. Resorbable SR devices, with their improved strength and dependability, have showed good long-term outcomes.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.