ISSN 229-548 Implantology 26; 2(): 2~2 Hiossen 임플란트에대한술자의주관적만족도및단기간임상평가 윤필영, 조용석 2, 김영균 분당서울대학교병원치과구강악안면외과, 2 앞선치과병원구강악안면외과 Subjective Satisfaction of Clinician and Short-term Clinical Evaluation of Hiossen Implant Pil-Young Yun, Yong-Seok Cho 2, Young-Kyun Kim Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital, Seongnam, Korea 2 Private Practice of Oral and Maxillofacial Surgery, Apsun Dental Hospital, Seoul, Korea Abstract Purpose: This study was to evaluate the subjective satisfaction about Hiossen implants. Materials and Methods: Hiossen implants were installed in 35 local dental clinics. Questionnaire study was performed about Hiossen and implant fixtures and surgical kits. Results: A total of 497 implants were installed. Most of them were installed in the lower and upper molar areas.very high satisfaction was shown for the ability to control implant placement depth. Conclusion: Comprehensive satisfaction evaluation was shown to be comparatively high, and a total of 73 of responders responded that they would recommend it to other clinicians. Key Words: Hiossen, subjective evaluation Reprint requests: Young-Kyun Kim Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital, 82 Gumi-ro 73beon-gil, Bundang-gu, Seongnam 362, Korea Tel: 82-3-787-754, Fax: 82-3-787-468 E-mail: kyk55@snubh.org Received for publication: March 2, 26 Revised for publication: March 4, 26 Accepted for publication: March 5, 26 교신저자 : 김영균 (362) 성남시분당구구미로 73 번길 82 분당서울대학교병원치과구강악안면외과 Tel: 82-3-787-754, Fax: 82-3-787-468 E-mail: kyk55@snubh.org 원고접수일 : 26 년 3 월 2 일원고수정일 : 26 년 3 월 4 일게재확정일 : 26 년 3 월 5 일 Copyright 26. The Korean Academy of Oral & Maxillofacial Implantology This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4./) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 2 Implantology Vol. 2 No., 26
I 서론 임플란트 fixture body design은크게 straight and tapered type으로구분되고있으며술자의선호도및임상적상황에따라선택되고있다. 최근에는식립의용이성, 우수한초기고정, 발치와즉시식립시장점등으로인해 tapered body implant의사용량이증가하고있다. Tapered body implant는피질골에집중되는응력을분산시켜변연골흡수를최소화할수있으며, 전치부의경우치조제의 undercut에서열개나천공을만들지않으면서수술할수있고, 주위치근이인접해있는경우치근을피해서심을수있는장점이있다고알려져있다,2. Nedir 등 3 은상악잔존골이 6 mm 이내일경우에도초기안정성이우수하며, 부하후에도변연골흡수를줄일수있다고하였다. Implant와 abutment 의 connection 방식에따라 internal vs external connection 이있으며각각의장단점이있다. 또한 Branemark implant 계열의 submerged type 과 Straumann ITI 계열의 nonsubmerged type이있으며, 2가지방식이혼용되어사용될수있는 system도있다. 술자의선호도및임상적상황에따라다양한종류의 implant들이사용되고있다. Microthread는 crestal bone 에가해지는 shear force를감소시키면서 crestal bone loss를최소화할수있다는장점이제기되면서최근 implant 상단에 microthread를채택한 system이많이출시되었다 4,5. Hiossen implant는모두 resorbable blast media (RBM) surface를채택하고있으며 는 tapered, single pitch micro thread and corkscrew thread design을가지고있고 internal connection type의 implant이다. 임상적 상황에따라 submerged or nonsubmerged technique 으로시술될수있다. 는 internal connection type의 straight body implant이며 nonsubmerged technique 으로시술하는것이원칙인제품이다. 임플란트임상성적, 환자의만족도, 합병증등에대한논문은많이발표되었으나실제 user인치과의사들이느끼는주관적만족도에대한논문은발표된것이거의없다 6-. 따라서저자등은임플란트시술을활발히수행하고있는대한민국 35개의료기관에서 Hiossen 임플란트를식립하는과정에서술자가신제품에대해느끼는주관적만족도를평가함으로써새로개발된임플란트의장단점을분석하고자본연구를시행하게되었다. II 연구재료및방법 35개치과의원을대상으로설문조사를시행하였다. 사용자들에게 Hiossen, implant fixture와 surgical kit (Hiossen Inc., Fairless Hills, PA, USA) 및사용자매뉴얼을제공하고조사설문지를배포하였다. 식립수술은 29년 3월부터 6월까지시행되었다 (Fig., 2). 3개치과의원에서 332개의 implants에대한회신이있었고, 2개치과의원에서 65개의 implants에대한회신이있었다. 식립부위에대한설문에서는 497개의 Hiossen implants 중 476개에대해서정확한답변이있었으며하악구치부와상악구치부에가장많이식립되었다 (Table ). 식립당시골질을치과의사의주관적판단에따라 hard, normal, soft 로구분하여조사하였다. 468개의임플란트에대한답변이있었으며 normal bone 이 33개로가장많았고 soft bone 27개, hard bone 38개였다 (Table 2). 대한구강악안면임프란트학회지 2 권 호, 26 3
Original Article A B C D E Fig.. Case reports of Hiossen treatment. (A) The periapical radiography in first diagnosis (#~#22). It was planned to conduct implant placement immediately after tooth extraction. (B) Oral radiography in first diagnosis. (C) Implant placed immediately after tooth extraction. Placed with non-submerged technique. (D) Periapical radiography two year after the final prosthesis is installed. The crestal bone level has stably been maintained. (E) Oral radiography two year after the final prosthesis is installed. 설문조사항목은다음과같았으며 35개의료기관에서식립된 497개임플란트에대해답변하였다.. 임상적평가식립방향의수정능력, self-tapping 능력, 식립감, 식립깊이조절능력, 초기고정력, 권장술식의적절성에대한평가가이루어졌다. 2. 종합의견설문서 Surgical kit 구성, Hiossen implant에대한종합만족도, 타치과의사에게권장할의향이있는지에대한평가가이루어졌다. III 연구결과. 임상적평가 ) 식립방향의수정능력 Drilling hole 입구에서 fixture가헛돌지않고방향을잘유지하면서식립이가능하였는지및잘못된방향을쉽게수정할수있었는지를평가하는항목이다. 총 497개중 486개의임플란트에대한평가가수집되었으며 의경우 45 (46개) 는선호제품보다용이하다고했고, 4 Implantology Vol. 2 No., 26
A B C D E Fig. 2. Case reports of Hiossen treatment. (A) The periapical radiography in first diagnosis (#36, #37). It was planned to conduct implant placement immediately after tooth extraction. (B) Oral radiography in first diagnosis. (C) #36, #37 implant placed immediately after tooth extraction. It was placed with non-submerged technique and connected with healing abutment. (D) Periapical radiography one year after the final prosthesis is installed. The crestal bone has stably been maintained. (E) Oral radiography one year after the final prosthesis is installed. Table. State of Hiossen implant placement Placement position Maxillary Incisors Molars Mandibular Incisors Molars Not responded: 2. placed implants 28 93 5 24 476 49 (58개) 는차이가없다고했으며, 6 (9개) 는선호제품보다용이하지않다고했다. 의경우 42 (68 개 ) 는용이하다고했고, 57 (93개) 는차이가없다고했으며 (2개) 는선호제품보다나쁘다고답하였다 (Fig. Table 2. Bone qualities in placing implants 3, Table 3). Bone Hard Normal Soft Not responded: 29. 38 33 27 468 2) Self-tapping 능력 Fixture가 bone 을파고드는성능 (self-tapping) 이우수한지평가하는항목이다. 총 497개중 486개의임플란트 대한구강악안면임프란트학회지 2 권 호, 26 5
Original Article 9 8 7 6 5 4 3 2 6 49 Path correction Easy Not easy 57 45 42 9 8 7 6 5 4 3 2 5 53 Self-tapping Excellent Not excellent 58 4 42 Fig. 3. Results of the ability to correct placement path (n=486). Table 3. Results of the ability to correct placement path (n=486) Path correction Easy Not easy Not responded:. 46 58 9 323 68 93 2 63 24 25 2 486 에대한평가결과가수집되었으며 의경우 4 (34개) 는선호제품보다 self-tapping 능력이더우수하다고했고, 53 (72개) 는차이가없다고했으며, 5 (7 개 ) 는선호제품보다나쁘다고했다. 의경우 42 (68개) 는선호제품보다 self-tapping 능력이더우수하다고했고, 58 (95개) 는차이가없다고했다고답하였다 (Fig. 4, Table 4). Fig. 4. Results of self-tapping capability (n=486). Table 4. Results of self-tapping capability (n=486) Self-tapping Excellent Not excellent Not responded:. 3) 식립감 34 72 7 323 68 95 63 22 267 7 486 우수한식립감을 초기에낮은토크 (torque) 로들어가서끝에이르러완만한토크상승으로조여주는느낌 으로정의할때술자가주관적으로느끼는식립감을평가하는항목이다. 총 497개중 486개의임플란트에대한평가가조사되었으며, 의경우 46 (5개) 는선호제품보다우수하다고했고, 48 (54개) 는차이가없다고했으며, 6 (9개) 는선호제품보다나쁘다고했다. 의경우 33 (53개) 는우수하다고했고, 66 (7 개 ) 는차이가없다고했으며 2 (3개) 는선호제품보다나 6 Implantology Vol. 2 No., 26
9 8 7 6 5 4 3 2 6 48 46 Feeling of placement Excellent Not excellent Fig. 5. Results of feeling of placement (n=486). 2 66 33 9 8 7 6 5 4 3 2 2 6 36 2 Placement depth Yes supra Yes crestal Yes sub No more placed No less placed Fig. 6. Results of placement depth (n=486). 42 42 5 Table 5. Results of feeling of placement (n=486) Feeling of placement Excellent Not excellent Not responded:. 5 54 9 323 쁘다고답하였다 (Fig. 5, Table 5). 53 7 3 63 23 26 22 486 Table 6. Results of placement depth (n=486) Placement depth Yes Supra Crestal Sub No More placed Less placed Not responded:. 5 5 94 8 323 25 69 68 63 3 84 262 9 486 4) 식립깊이조절능력 Fixture를원하는깊이 (depth) 까지식립하는것이용이하였는지, 원하는깊이보다더혹은덜식립된상태에서깊이수정이용이하였는지를평가하는항목이다. 원하는깊이까지식립하는것이용이하였는지에대한설문은총 497개중 486개의임플란트에대한평가가조사되었다. 의경우 2 (5개) 는 supra로원하는깊이로식립가능했고, 36 (5개) 는 crestal로원하는깊이로식립가 능했으며, 6 (94개) 는 sub로원하는깊이만큼식립가능했고, (개) 는더깊이식립되었고, 2 (8개) 는얕게식립되었다. 의경우 5 (25개) 는 supra로원하는깊이로식립가능했고, 42 (69개) 는 crestal로원하는깊이로식립가능했으며, 42 (68개) 는 sub로원하는깊이만큼식립가능했고, (개) 는덜식립되었다 (Fig. 6, Table 6). 깊이수정에대한설문은총 497개중 482개의임플란 대한구강악안면임프란트학회지 2 권 호, 26 7
Original Article 9 8 7 6 5 4 3 2 8 92 Depth correction Easy Difficult 99 9 8 7 6 5 4 3 2 Initial fixation power 5 Easy Difficult 48 47 3 63 34 Fig. 7. Results of easiness of depth correction (n=482). Table 7. Results of easiness of depth correction (n=482) Depth correction Easy Difficult Not responded: 5. 293 27 32 6 62 454 28 482 트에대한평가가조사되었으며 의경우 92 (293 개 ) 는용이하다고했고, 8 (27개) 는어렵다고했다. HS II의경우 99 (6개) 는용이하다고했고, (개) 는어렵다고했다 (Fig. 7, Table 7). 5) 초기고정력초기고정력확보가용이하였는지평가하는항목이다. 총 497개중 486개의임플란트에대한평가가조사되었으며 의경우 47 (53개) 는선호제품보다용이하다고했고, 48 (55개) 는차이가없다고했으며, 5 (5 Fig. 8. Results of easiness to obtain initial fixation power (n=486). Table 8. Results of easiness to obtain initial fixation power (n=486) Initial fixation power Easy Difficult Not responded:. 53 55 5 323 55 3 5 63 28 258 2 486 개 ) 는선호제품보다어렵다고했다. 의경우 34 (55개) 는용이하다고했고, 63 (3개) 는차이가없다고했으며 3 (5개) 는선호제품보다어렵다고답하였다 (Fig. 8, Table 8). 6) 권장술식의적절성 35명의치과의사들이응답하였으며 94 (33명) 는권장술식이적절하다고하였으나 3 (명) 는차이를모르겠다고하였고, 3 (명) 는부적절하다고답하였다 (Table 9). 8 Implantology Vol. 2 No., 26
Table 9. Relevance to recommended treatment (n=35) Recommended treatment Relevant Irrelevant 33 35 94 3 3 Table. Results of kit structure (n=2) Kit structure Relevant Not responded: 23. 2 92 8 Table. Results of comprehensive satisfaction (n=34) Comprehensive satisfaction Most cases Some cases Improvement is desired Not responded:. 22 2 34 65 29 6 Table 2. Results of intent to recommend (n=33) Intent to recommend Have an intent Don t know Not responded: 2. 24 9 33 73 27 2. 종합의견설문지분석결과 ) Hiossen implant kit의구성및배치가적절하였습니까? 2명의치과의사들이응답하였으며 92 (명) 는 Hiossen의 kit의구성및배치가적절했다고하였으며, 8 (명) 는차이를모르겠다고답하였다 (Table ). 2) Hiossen implant를사용하신후종합적인만족도는어떻습니까? 34명이응답하였으며 65 (22명) 는대부분의 case에서만족하였으며, 29 (명) 는일부 case에서만족하였고, 6 (2명) 는특정기능의개선을바란다고답하였다. 불만족으로답변한경우는없었다 (Table ). 3) Hiossen implant 제품을타임상의에게권장할의향이있습니까? 33명이응답하였으며 73 (24명) 는타임상의에게권장할의향이있다고하였고, 27 (9명) 는모르겠다고답하였다. 의향이없다고답한경우는없었다 (Table 2). IV 총괄및고찰 Hiossen 임플란트는모두 hydroxyapatite powder 를이용한 RBM surface를적용하고있으며 surface roughness는.2~.8 μm Ra 값을나타내고있다. Hiossen HG II implant fixture는상단에서는 microthread를부여함 대한구강악안면임프란트학회지 2 권 호, 26 9
Original Article 으로써응력분산으로인한치조정골흡수를최소화하면서초기고정력을증대시킬수있도록하였다. 중앙부분에는 dual thread를채택함으로써식립도중에급격한 Fig. 9. Hiossen implant design. 식립토크상승을억제하는효과를얻을수있다. 하단에서는 macrothread를부여함으로써 self-tapping 능력과식립시방향수정이용이하도록하였다. 또한골조직에파고드는성능과하단부에서고정능력을향상시킬수있도록설계되었다. Supra-structure와의연결은 internal o Morse taper connection 방식을채택하고있다 (Fig. 9). Hiossen implant fixture는 straight body with expanded thread 형태로서상단은 trans-gingival portion with machined surface로구성되어있고 apex area는 3 round cutting edge design으로구성되어있다. 제조사측에서는 는 good self-tapping capability, good initial stability and occlusal force distribution 효과를얻을수있도록디자인된제품이라고언급하고있다. Supra-structure와연결방식은 internal 8 o Morse taper connection 을채택하고있다 (Fig. ). 임플란트시술후환자들의만족도평가, 합병증및임플란트의임상성적에대한논문들은많이발표되었지만 Platform Octa: 2.9 mm G/H L Octa type Apex Fig.. Hiossen implant design. G/H: gingival height, L: length. Pil-Young Yun et al. : Subjective Satisfaction of Clinician and Short-term Clinical Evaluation of Hiossen Implant. Implantology 26 Implantology Vol. 2 No., 26
사용자인임상의들의주관적만족도를평가한논문은매우드물다. Kim 은 tapered body (Osstem GS III) 임플란트식립과관련된사용자만족도평가에대한논문을발표한바있다. 설문결과초기고정력확보, 골조직에파고드는능력, 식립깊이조절능력에대한만족도가높았다. 반면원하는방향으로식립조절가능성에대한평가는타제품들과큰차이를보이지않았고대부분의사용자들이제조사측에서제시하는술식을준수하지않았다고보고하였다. 본연구에서 Hiossen implant는대부분구치부에식립되었으며식립당시주관적으로느낀골질의강도는 normal and soft bone이대부분을차지하였다. Pacement path 수정능력에대한설문에서는 의경우 45, 의경우 42 에서용이하였다고답했으나선호하는타제품들과큰차이를느끼지못하였다는경우가많은비율을차지하였다. 제조사측에서는 fixture corkscrew thread 부위에 cutting edge가있어측벽에걸리는절삭저항을감소시켜쉽게식립방향을수정할수있다고주장한다 2. Self-tapping 능력에대한설문에서는 의 4, 의 42 에서선호제품대비우수하다고응답하였으나선호하는타제품들과큰차이를느끼지못하였다는경우가많은비율을차지하였다. 식립감은 의 46, 의 33 에서선호제품보다우수하다고응답하였으나타제품들과큰차이를느끼지못하였다는경우가많은비율을차지하였다. 초기고정력확보에관한설문조사에서 의 47, 의 34 가타제품에비해용이하다고답하였으나, 큰차이가없다고응답한사용자들이더많은비율을차지하였다. 식립깊이조절능력에대한설문에서는, 제품의대부분이원하는깊이까지용이하게식립할수있었다고응답하였다. 또한대부분의사용자들이식립깊이를수정하는것이매우수월하였다고대답하였다. 제조사측에서는식립시토크값이모든골질에서 3~4 Ncm의범위에들어가도록최적화하였다고주장한다. 4 Ncm 이하로제한한이유는과도한토크로인해변연골흡수가진행되는것을방지하기위함이라고하였다 2. 제조사측에서제시하는권장술식의적절성에대한평가에서대부분의응답자들이적절하다고답하였다. 식립을위한 drilling sequence, rpm, insertion torque, cortical drilling을위한지침등을상세히그림과함께제공하는것은사용자들에게매우중요하다. 권장술식을미준수할경우초기고정력확보등에악영향을미치기때문에임플란트성패와직간접적인관련성이있을수있다. Tapered body implant with microthread design을식립할때 normal bone에서 cortical drilling or countersinking을시행하지않거나식립토크가적정수준을벗어나게되면 crestal bone 에과도한 compression 이가해지게되고치유과정중에치조정골흡수등의원인이될수있다 3. Hiossen implant에대한종합의견설문에서는 kit의구성및배치에대한의견, 종합적인만족도, 타임상의에게권장할의향을물은결과대부분긍정적인응답을보였으며사용자측면에서대체로만족하는결과를보였다. V 결론 이상의연구결과를살펴볼때 Hiossen implant system 에대한전반적인만족도는높았으며식립깊이조절능력에서가장높은만족감을보였다. 대한구강악안면임프란트학회지 2 권 호, 26
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