• 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.

• The Journal of Korean Academy of Prosthodontics
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• v.45 no.3
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• pp.362-374
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• 2007

Statement of problem. The intial stability for osseointegration of implant has been an interesting factor. Especially, in the case of poor bone quality or immediately loaded implant, various strategies have been developed focusing on the surface of materials to improve implant fixation to bone. The microscopic properties of implant surfaces play a major role in the osseous healing of dental implants. Purpose. The aims of this study are to perform a histologic and histomorphometric comparison of the healing characteristics of three different surfaces and the comparison of resonance frequency analysis (RFA) values measured by $Osstell^{TM}$ and perio-test values (PTV) measured by Periotest. Material and methods. A total of 24 screw titanium implants (Dentium Co., Seoul, Korea) with 6mm in length and 3.4mm in diameter, were placed in the mandible of 4 beagle dogs. Implants were divided into three groups following the surface treatment methods: Group I is machined(control group). Group II is anodically oxidized. Group III is coated 500nm in thickness with hydroxyapatite(HA) by ion beam assisted deposition(IBAD) on the anodized oxidization. Bone blocks from 2 dogs were caught after 3 weeks of covered healing and another blocks from 2 dogs after 6 weeks. RFA values and PTV were measured right after insertion and at 3 and 6weeks. Histomorphometric analysis was made with Kappa Image Base System to calculate bone-to-implant contact (BIC) and bone area inside the threads. Pearson's correlation analyses were performed to evaluate the correlation between RFA and PTV, BIC and bone area ratio of three different surfaces at 3 and 6 weeks. Results. 1) In all surface treatment methods, the RFA values decreased and the PTV values increased until 6 weeks in comparison to initial values. 2) At 3 weeks, no significant difference was found from bone-to-implant contact ratio and bone area ratio of three different surface treatment methods(P>0.05). However, at 6 weeks, different surface treatment methods showed significantly different bone-toimplant contact ratio and bone area ratio(P<0.05). 3) In the implants with the IBAD on the anodic oxidization, significant difference was found between the 3 weeks and the 6 weeks bone area ratio(P<0.05). 4) Correlation was found between the RFA values and the bone area ratio at 3 and 6 weeks with significant difference(P<0.05). Conclusions. These results indicate that the implants with the IBAD on the anodic oxidization may have a high influence on the initial stability of implant.

• The Korean Society of Law and Medicine
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• v.17 no.1
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• pp.281-297
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• 2016

In order to make a treatment plan and outcome prediction, it is important to evaluate accurately and objectively osseous tissues of the implant area. The evaluation of osseous tissues is the most objective method for the decision of production time of upper structure of alveolar bone. However, the evaluation of osseous tissues contains contradiction because it is made by subjective opinions of dental surgeons. Many dentists also point out the problem of subjective evaluation of osseous tissues. Therefore, it is necessary to create accurate and objective standards. Previously, the evaluation of bone density depends on dentist's subjective sensation during drilling procedure of implant. However, the HU(Hounsfield unit) figure of CT(computed tomography) scan allows of objective and precise categorization of bone density now. Misch and Kircos divided the bone density levels from D1 to D5 with subjective separation of bone density. Their method also depended on not objective and quantification data but subjective separation by sensation. Thus, we need the evaluation of implant area through comparative analysis of more objective and quantification data. Implant treatment comprises the highest frequency of medical disputes of dental clinic. If we bring objective checkup and reasonable treatment method in the implant treatment, we can deduce more reasonable results, and the failure late of implant treatment also can decrease. The ultimate objective of this study is the minimization of dental disputes between dental patients and dentists by creating new legal standards on the basis of objective and quantification data.

• Journal of Periodontal and Implant Science
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• v.42 no.6
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• pp.204-211
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• 2012

Purpose: This study was performed to establish an experimental rabbit model for single-stage maxillary sinus augmentation with simultaneous implant placement. Methods: Twelve mature New Zealand white rabbits were used for the experiments. The rabbit maxillary sinuses were divided into 3 groups according to sinus augmentation materials: blood clot (BC), autogenous bone (AB), and bovine-derived hydroxyapatite (BHA). Small titanium implants were simultaneously placed in the animals during the sinus augmentation procedure. The rabbits were sacrificed 4 and 8 weeks after surgery and were observed histologically. Histomorphometric analyses using image analysis software were also performed to evaluate the parameters related to bone regeneration and implant-bone integration. Results: The BC group showed an evident collapse of the sinus membrane and limited new bone formation around the original sinus floor at 4 and 8 weeks. In the AB group, the sinus membrane was well retained above the implant apex, and new bone formation was significant at both examination periods. The BHA group also showed retention of the elevated sinus membrane above the screw apex and evident new bone formation at both points in time. The total area of the mineral component (TMA) in the area of interest and the bone-to-implant contact did not show any significant differences among all the groups. In the AB group, the TMA had significantly decreased from 4 to 8 weeks. Conclusions: Within the limits of this study, the rabbit sinus model showed satisfactory results in the comparison of different grafting conditions in single-stage sinus floor elevation with simultaneous implant placement. We found that the rabbit model was useful for maxillary sinus augmentation with simultaneous implant placement.

• Journal of Dental Rehabilitation and Applied Science
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• v.26 no.3
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• pp.273-283
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• 2010

This study evaluated the effect of 3 different compatible screws on the detorque values in a multiple implant-supported superstructure and single implant abutments. An implant superstructure directly connected to 4 implants was screwed to 6 experimental dental stone casts made by acrylic resin splinted impressions, using 20 Ncm. The detorque values of screws were measured twice. Three compatible abutment screws used in this study were TorqTite screw, Gold-Tite screw, and, Titanium screw. And, using single implant abutments (GoldAdapt Engaging abutments), the detorque values of 3 different screws were measured twice on 2 implants of 5 experimental casts. According to statistical analysis of detorque values using mixed model at a .05 level of significance, no statistically significant differences among 3 different compatible screws were found in a multiple implant-supported superstructure (p>0.05). But, in single implant abutments, statistically significant differences among 3 different compatible screws were found (p=0.0175). The detorque values of TorqTite(p=0.0462) and Titanium(p=0.0348) screws were significantly higher than those of Gold-Tite screw, but no statisticantly significantlydifferences were found between TorqTite and Titanium screws(p>0.05). Therefore, various compatible screws showed significant effects on the detorque values for single implant abutment, but, showed no significant effects for a multiple implant-supported superstructure.

• Journal of Periodontal and Implant Science
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• v.50 no.3
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• pp.183-196
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• 2020

Purpose: This practice-based cross-sectional study aimed to investigate whether common risk indicators for peri-implant diseases were associated with peri-implant mucositis and peri-implantitis in patients undergoing supportive implant therapy (SIT) at least 5 years after implant restoration. Methods: Patients exclusively restored with a single implant type were included. Probing pocket depth (PPD), bleeding on probing (BOP), suppuration, and radiographic bone loss (RBL) were assessed around implants. The case definitions were as follows: peri-implant mucositis: PPD ≥4 mm, BOP, no RBL; and peri-implantitis: PPD ≥5 mm, BOP, RBL ≥3.5 mm. Possible risk indicators were compared between patients with and without mucositis and peri-implantitis using the Fisher exact test and the Wilcoxon rank-sum test, as well as a multiple logistic regression model for variables showing significance (P<0.05). Results: Eighty-four patients with 169 implants (observational period: 5.8±0.86 years) were included. A patient-based prevalence of 52% for peri-implant mucositis and 18% for peri-implantitis was detected. The presence of 3 or more implants (odds ratio [OR], 4.43; 95 confidence interval [CI], 1.36-15.05; P=0.0136) was significantly associated with an increased risk for mucositis. Smoking was significantly associated with an increased risk for peri-implantitis (OR, 5.89; 95% CI, 1.27-24.58; P=0.0231), while the presence of keratinized mucosa around implants was associated with a lower risk for peri-implantitis (OR, 0.05; 95% CI, 0.01-0.25; P<0.001). Conclusions: The number of implants should be considered in strategies to prevent mucositis. Furthermore, smoking and the absence of keratinized mucosa were the strongest risk indicators for peri-implantitis in patients undergoing SIT in the present study.

• Archives of Plastic Surgery
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• v.50 no.2
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• pp.160-165
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• 2023

Background The number of cosmetic and reconstructive surgeries that use breast implants is increasing in Korea. Recently, it has been reported that breast implant-associated anaplastic large-cell lymphoma is related to textured breast implants, and interest in classification according to the texture of breast implants is increasing. However, there is currently no clear and unified classification. In particular, the definition of "microtextured" is highly varied. In this study, we retrospectively investigated and analyzed the clinical outcomes of smooth and microtextured breast implants. Methods A retrospective chart review of all patients who underwent breast augmentation surgery with smooth and microtextured silicone gel implants between January 2016 and July 2020 was performed. We retrospectively analyzed implant manufacturer, age, body mass index (BMI), smoking status, incision location, implant size, follow-up period, complications, and reoperation rate. Results A total of 266 patients underwent breast augmentation surgery, of which 181 used smooth silicone gel implants and 85 used microtextured silicone gel implants. Age, BMI, smoking status, implant size, and follow-up period were not significantly different between the two groups. Similarly, complications and reoperation rates were not significantly different between the two groups. Conclusion It is important to provide information regarding the clinical risks and benefits of breast implants to surgeons and patients through a clear and unified classification according to the texture of the breast implant.

• Journal of Korean society of Dental Hygiene
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• v.4 no.2
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• pp.237-253
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• 2004

This study was to find a patient's motive for receiving implant treatment by age and gender using a self-reporting questionnaire survey with adults(men & women) in Woolsan. The result was as follows: 1. As a result of questionnaire survey with 155 patients in total(86 men, 69 women), 24 of 86 men(27.9%) valued the natural mastication feature of dental implant most, that is as similar as natural teeth, while 18 of 69 women(26.1%) had the most priority over the longer life of implant than common dental prostheses. By age, those in their 20s and 30s had a preference to implant treatment because it does not need to pulling out teeth for prostheses, while those in their 40s and over had a priority to the natural mastication feature of implant that is similar as much as natural teeth. By dental treatment, all of respondents said that the natural mastication feature is the most important in getting dental implant. It was founded that whether one can taste food as it is or not is less important, regardless of age or gender. 2. The greatest obstacle to implant surgery was expensive medical fees, 88 of 155 respondents(56.8%), with a fear of surgery itself being the least obstacle. 3. 90.2% of the total respondents said that they will want to receive dental implant treatment if their economy allow.

• The Journal of Advanced Prosthodontics
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• v.3 no.2
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• pp.76-80
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• 2011

PURPOSE. Implant stability quotient (ISQ) values have been supposed to predict implant stability. However, the relationship between ISQ values and bone-to-implant contact ratio (BIC%) which is one of the predictors of implant stability is still unclear. The aim of the present study was to evaluate initial ISQ values in relation to BIC% using rabbit model. MATERIALS AND METHODS. Four New Zealand white rabbits received a total of 16 implants in their tibia. Immediately after implant placement ISQ values were assessed. The measurements were repeated at the time of sacrifice of the rabbits after 4 weeks. Peri-implant bone regeneration was assessed histomorphometrically by measuring BIC% and bone volume to total volume values (bone volume %). The relationships between ISQ values and the histomorphometric output were assessed, and then, the osseointegration prediction model via the initial ISQ values was processed. RESULTS. Initial ISQ values showed significant correlation with the BIC%. The bone volume % did not show any significant association with the ISQ values. CONCLUSION. In the limitation of this study, resonance frequency analysis is a useful clinical method to predict the BIC% values and examine the implant stability.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.27 no.1
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• pp.39-47
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• 2005

The purpose of this study is to review the prognosis of the TG Osseotite implant(3i Co, USA) placed in partial edentulous area of oral cavity and to suspect the possible causes leading to failure. 124 TG Osseotite implants that had been inserted between 2000 - 2002 were followed up for 2 years(avg : 9.5 months) in function. Medical records, and radiographs were evaluated and analyzed by the over all success rate, gender and age factor, general disease, implant fixture length and diameter, implant site, bone density, and various surgical methods. Chi square test was used statistically. Of the 124 TG Osseotite implants, 9 implants(7.3%) were removed in early phase and 3 implants(2.4%) were in late phase. The cumulative survival rate was 90.2%. The failure of the TG Osseotite implant was closely related with the use of bone graft techniques such as sinus elevation or immediate implantation and not with the age, sex, general disease, implant site, bone density of implanted site. The failure of the TG Osseotite implant was well developed when it was the wide type of implant and it was inserted for single tooth replacement. The developement of peri-implantitis was the most important factor in the failure of the TG Osseotite implant.