Donald S. Clem, Pamela K. McClain, Michael K. McGuire, Chris R. Richardson, Greg A. Santarelli, Rachel A. Schallhorn, E. Todd Scheyer, John C. Gunsolley, Thiago Morelli
{"title":"用于现有种植体周围软组织体积增大的收获移植替代物:随机、对照和盲法多中心试验","authors":"Donald S. Clem, Pamela K. McClain, Michael K. McGuire, Chris R. Richardson, Greg A. Santarelli, Rachel A. Schallhorn, E. Todd Scheyer, John C. Gunsolley, Thiago Morelli","doi":"10.1002/JPER.23-0305","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Using a single-blind, randomized, controlled, multicenter, practice-based clinical trial, a volume-stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient-reported outcomes (PRO).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>There were no significant differences between test and control patient demographics or clinical measures throughout the 1-year study. VCMX “grafts” were by design larger than CTG, and surgery time was less (27% less, <i>p</i> = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (<i>p</i> < 0.0001), but all other PRO measures, including esthetics and satisfaction, improved similarly for both therapies.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Given the inclusion criteria for this study, namely soft tissue augmentation around existing implants with some evidence of KTw and minimal recession, VCMX provided soft tissue thickness and volume increases similar (noninferior) to CTG. Clinical measures and PRO were similar between therapies—site sensitivity and esthetics improved similarly for both therapies—but surgery time and pain following surgery were significantly less for VCMX.</p>\n </section>\n </div>","PeriodicalId":16716,"journal":{"name":"Journal of periodontology","volume":"95 8","pages":"740-748"},"PeriodicalIF":4.2000,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial\",\"authors\":\"Donald S. Clem, Pamela K. McClain, Michael K. McGuire, Chris R. Richardson, Greg A. Santarelli, Rachel A. Schallhorn, E. Todd Scheyer, John C. Gunsolley, Thiago Morelli\",\"doi\":\"10.1002/JPER.23-0305\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Using a single-blind, randomized, controlled, multicenter, practice-based clinical trial, a volume-stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient-reported outcomes (PRO).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>There were no significant differences between test and control patient demographics or clinical measures throughout the 1-year study. VCMX “grafts” were by design larger than CTG, and surgery time was less (27% less, <i>p</i> = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (<i>p</i> < 0.0001), but all other PRO measures, including esthetics and satisfaction, improved similarly for both therapies.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Given the inclusion criteria for this study, namely soft tissue augmentation around existing implants with some evidence of KTw and minimal recession, VCMX provided soft tissue thickness and volume increases similar (noninferior) to CTG. Clinical measures and PRO were similar between therapies—site sensitivity and esthetics improved similarly for both therapies—but surgery time and pain following surgery were significantly less for VCMX.</p>\\n </section>\\n </div>\",\"PeriodicalId\":16716,\"journal\":{\"name\":\"Journal of periodontology\",\"volume\":\"95 8\",\"pages\":\"740-748\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2023-12-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of periodontology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/JPER.23-0305\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DENTISTRY, ORAL SURGERY & MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of periodontology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/JPER.23-0305","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}
Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial
Background
Using a single-blind, randomized, controlled, multicenter, practice-based clinical trial, a volume-stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants.
Methods
Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient-reported outcomes (PRO).
Results
There were no significant differences between test and control patient demographics or clinical measures throughout the 1-year study. VCMX “grafts” were by design larger than CTG, and surgery time was less (27% less, p = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (p < 0.0001), but all other PRO measures, including esthetics and satisfaction, improved similarly for both therapies.
Conclusions
Given the inclusion criteria for this study, namely soft tissue augmentation around existing implants with some evidence of KTw and minimal recession, VCMX provided soft tissue thickness and volume increases similar (noninferior) to CTG. Clinical measures and PRO were similar between therapies—site sensitivity and esthetics improved similarly for both therapies—but surgery time and pain following surgery were significantly less for VCMX.