• Journal of the Korean Society of Safety
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• v.27 no.2
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• pp.92-97
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• 2012

Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.39 no.2
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• pp.43-54
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• 2013

In an attempt to regain function and aesthetics in the craniofacial region, different biomaterials, including titanium, hydroxyapatite, biodegradable polymers and composites, have been widely used as a result of the loss of craniofacial bone. Although these materials presented favorable success rates, osseointegration and antibacterial properties are often hard to achieve. Although bone-implant interactions are highly dependent on the implant's surface characteristics, infections following traumatic craniofacial injuries are common. As such, poor osseointegration and infections are two of the many causes of implant failure. Further, as increasingly complex dental repairs are attempted, the likelihood of infection in these implants has also been on the rise. For these reasons, the treatment of craniofacial bone defects and dental repairs for long-term success remains a challenge. Various approaches to reduce the rate of infection and improve osseointegration have been investigated. Furthermore, recent and planned tissue engineering developments are aimed at improving the implants' physical and biological properties by improving their surfaces in order to develop craniofacial bone substitutes that will restore, maintain and improve tissue function. In this review, the commonly used biomaterials for craniofacial bone restoration and dental repair, as well as surface modification techniques, antibacterial surfaces and coatings are discussed.

• The Journal of Korean Academy of Prosthodontics
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• v.39 no.6
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• pp.698-708
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• 2001

This study was to evaluate the clinical evidence for the success and the predictability of the osseointegrated dental implants in the partially edentulous Korean patients. 201 patients have received total of 502 Branemark implants, which were restored with either single or multiunit fixed superstructures at the Implants Clinic, Yonsei University Dental Hospital. The clinical and radiographic evaluations carried out on the patients for maximum 8 years were assessed annually for peri-implant inflammation, implant mobility (PTV), Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Keratinized Mucosa width and any changes in the surrounding bone level. The radiographs were taken at completion of the restoration, and annually thereafter. On the last recall appointments the patients filled a questionnaire consist of 29 questions in four categories. The cumulative non-failure rate of success was 93.9%. The first year mean bone loss was 0.3mm and less than 0.2mm annually thereafter. The periodontal parameters, keratinized tissue width and periotest values stabilized after initial changes in the first few years. The questionnaire has shown general satisfactory responses in all four aspect of dental implants treatment, including chewing efficacy, comfort, aesthetics and speech. The results support the predictability and success of the long-term rehabilitation of implant supported prostheses in partially edentulous Korean patients.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.35 no.4
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• pp.276-279
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• 2009

The aim of this case study was to report the clinical outcome of immediate provisionalization using one-piece narrow diameter (3.0mm) implants in missing maxillary lateral or mandibular incisors. The present study included 36 patients who were treated with 62 one-piece narrow diameter implants. After implant placement, immediate provisional restorations were delivered. All implants showed favorable osseointegration and after progressive loading from 3 months to 9 months (average of 5 months), final restorations were completed without failure in all cases. A survival rate of 100 % (62 of 62) was observed up to 23 months of observation (average of 12.6 months).

• The Journal of Korean Academy of Prosthodontics
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• v.38 no.6
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• pp.765-781
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• 2000

The purpose of this study was to compare the screw loosening characteristics of three avail-able cementation type abutments: one-piece cementation type abutment; two-piece cementation type abutment using titanium abutment screw; two-piece cementation type abutment using gold abutment screw. Two implant supported three-unit superstructures were fabricated using a pair of 3 kinds of abutments for each experimental model. Cyclic loading was applied on the specimen, and made to stop when the superstructure showed movement over threshold range. The loaded cycle was counted until the machine stopped. Frequency analysis was done to measure the change of natural frequency before and after the application of cyclic load and to find the effect of screw loosening on the change of natural frequency. The specimen assembly was modeled to perform the finite element analysis to see the distribution of the stress induced by the application of preload over the screw joint and to compare the pattern of the distribution of stress induced by the external force with the change of the preload condition. The following results were obtained: 1. The failure loading cycle of two-piece cementation type abutment using gold screw was significantly greater than those of the other groups. 2. One-piece cementation type abutment applied to multi-unit restoration case did not show greater resistance to screw loosening compared to two-piece cementation type abutments. 3. Frequency analysis showed decrease in natural frequency when screw loosening occured.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.46 no.6
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• pp.417-421
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• 2020

Objectives: The purpose of this paper is to introduce an effective technique to easily obtain adequate amounts of keratinized gingiva and vestibular depth. Materials and Methods: Free gingiva (vertical height 10 mm) was harvested on the palatal mucosa and a partial thickness flap was elevated on the recipient site with same width as the free gingiva graft. After a conventional suture, a titanium mesh covered the graft and was fixed with miniscrews. Titanium mesh was removed 4.1±2.5 weeks after surgery. The amount of keratinized gingiva and vestibular depth was measured at the final follow-up. Results: Nine patients (males 4, females 5; 53.9±14.1 years) who underwent bone graft surgery before vestibuloplasty were included. No free gingival graft failure or complications were encountered in any of the patients. The relapse rate for vestibular depth (23.3%) was lower than that for keratinized gingiva (48.3%) after 34.4±14.4 months (P=0.010). Conclusion: Vestibuloplasty with a free gingival graft using titanium mesh could be achieved with an acceptable amount of keratinized gingiva and an appropriate vestibular depth around dental implant.

• Journal of Korean Dental Science
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• v.17 no.1
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• pp.45-52
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• 2024

Purpose: To investigate the 5-year outcome of dental implants placed in a grafted maxillary sinus using recombinant human bone morphogenetic protein-2 (rhBMP-2). Materials and Methods: We retrospectively analyzed 27 implants after maxillary sinus floor augmentation (MSFA) using rhBMP-2 in 16 patients between January 2016 and March 2017. The study evaluated two outcome variables: (1) 5-year cumulative survival and success rate of the implant after functional loading and (2) marginal bone loss (MBL) for implant failure. Results: The average residual bone height was 4.78±1.53 mm. The healing period before loading was 8.35±2.34 months. The crown-to-implant ratio was 1.31±0.26. The 5-year cumulative survival and success rate after functional loading were 100% and 96.3%, respectively. The 5-year average MLB was 0.89±0.82 mm. Conclusion: Placing dental implants with MSFA using rhBMP-2 is a reliable procedure with favorable long-term survival and success rates.

• Journal of Trauma and Injury
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• v.37 no.1
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• pp.89-96
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• 2024

The indications for total hip replacement are increasing and not limited to osteoarthritis. Total hip replacement may also be done for trauma and pathological fractures in patients otherwise physiologically fit and active. This trend has led to an inevitable rise in complications such as periprosthetic femoral fracture. Periprosthetic femoral fracture can be challenging due to poor bone quality, osteoporosis, and stress fractures. We present a case of periprosthetic femoral fracture in a 71-year-old woman with some components of an atypical femoral fracture. The fracture was internally fixed but was subsequently complicated by infection, implant failure needing revision, and later stress fracture. She was on a bisphosphonate after her index total hip replacement surgery for an impending pathological left proximal femur fracture, and this may have caused the later stress fracture. Unfortunately, she then experienced implant breakage (nonunion), which was treated with a biplanar locking plate and bone grafting. The patient finally regained her premorbid mobility 13 months after the last surgery and progressed satisfactorily towards bony union.

• Journal of Chest Surgery
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• v.29 no.10
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• pp.1111-1117
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• 1996

Structural deterioration of the bioprosthetic xenograft valves due to primary tissue failure occurs in two modes: from fatigue lesions with tear and wear with or without calcification and from calcification with obstruction. Two groups of consecutive 56 patients with the Hancock porcine ortic valve(HM) and of 1 13 patients with the standard-profile onescu-Shiley bovine pericardial valve(ISM) explanted from mitral position at the time of re-replacement surgery for primary tissue failure at Seoul national University Hospital until 1994, were studied for clinical and pathological features. Their ages at primary implant were 31.9 $\pm$9.2 years In HM and 30.4$\pm$ 12.5 years in ISM. Hemodrnamic dysfunction of the failed mitral bloprostheses were predominantly insufficiency in HM(64.3%) and stenosis in ISM(51.3%)(p<0.001). Pathologic findings of the explanted mitral valves reflected these hemodynamic changes, revealing failure more often from tissue damage(tears and wears) in HM and more often from calcification in ISM(p< 0.001). Explant period(from primary implant to explant) was relatively short in ISM(8.7$\pm$2.6years), compared with the one in HM(10.4 $\pm$2.6 years)(p<0.001). In conclusion, both the Hancock and the lonescu-shiley valves would fail from calcification as well as issue damage. However, while the Hancock porcine valves in mitral position failed more frequently from tissue failure and insufficiency, the standard-profile lonescu-Shiley pericardial valves did from calcification and stenosis, especially in young pAtients . Although the possibility of less occurrence of valve failure from mechanical reasons may be expected with newer generation bloprostheses, it does not seem to Improve durability significantly unless further refinement in antimineralization is achieved. Therefore, clinical use of the glutaraldehyde-treated bioprosthetic valves is, at present, limited to the patients of advanced age groups.

• Transactions of the Korean Society of Machine Tool Engineers
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• v.15 no.3
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• pp.127-131
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• 2006

Existing orthopedic implants such as pedicle screw and spinal cage were designed to fix the spinal structure. But, nowadays, physicians want to rehabilitate there original functions. To achieve this request, we studied micro-movable structure for interspinous. As a first step, we designed interspinous structure by 3D CAD to join each spinous processes. Next, we simulate it with various factors such as the thickness of micro-movement structure and the design of clip. At last, we performed static compressive test to satisfy the failure load of 339N and dynamic endurance test of 1.2M cycle. As a result, we developed interspinous implant and did several surgery to evaluated its satisfaction.