Reza A. Mokhtari DDS, Morgan Olsson DDS, Per-Olov Östman DDS, Christer Dahlin DDS, PhD
{"title":"一项随机、多中心、双盲平行研究，旨在评估唑来膦酸盐涂层与未涂层种植体在部分缺牙患者中的安全性和性能。","authors":"Reza A. Mokhtari DDS, Morgan Olsson DDS, Per-Olov Östman DDS, Christer Dahlin DDS, PhD","doi":"10.1111/cid.13288","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>To evaluate patient safety, implants survival and implant stability of the bisphosphonate (zoledronate) as a coating on dental implants in patients requiring oral rehabilitation in the posterior maxilla.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>In this multicenter, double-blind, randomized controlled study, 62 patients were randomized to receive either zoledronate-coated or uncoated control implants in the premolar or molar area of the maxilla, using a one stage-protocol. Due to dropouts and exclusion 49 patients completed the study. The implants were examined by resonance frequency analysis (RFA) using an implant stability quotient (ISQ) scale at the time of insertion, and at 8 weeks, and after 12 weeks prior to prosthetic restoration. Radiographs were taken prior to surgery, directly after insertion, and during the follow-up at 12 weeks, 6 months, and 1 year to analyze changes in marginal bone levels (MBL). Finally, all complications and adverse effects (AE) were observed and recorded.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Out of 62 included patients, 49 patients completed the study. No AE were reported by patients receiving zoledronate-coated implants. There was no statistically significant difference between the zoledronate-coated or uncoated implant groups when comparing ISQ levels at insertion and after 12 weeks of healing, the mean of the ISQ values demonstrated a change of 4.64 (95% confidence interval: 15.46; 5.79, <i>p</i> = 0.43) between the two groups. At 8- and 12-weeks, ISQ values remained stable (range 62–70). Radiographic analysis showed no statistically significant difference in MBL between the two implant groups after 1 year of loading neither at the mesial side (<i>p</i> = 0.99) or the distal side (<i>p</i> = 0.97). MBL for coated implants were 0.57 mm at the mesial side and 0.46 mm at the distal side. For the uncoated implants, MBL was 0.48 mm at the mesial side and 0.47 mm at the distal side.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>The zoledronate-coated dental implants are safe to use in a one-stage surgery protocol in patients requiring oral rehabilitation in the posterior maxilla, after 1 year of loading. There were no statically significant changes in implant stability and marginal bone levels measured by intraoral radiographs in comparison to uncoated control implants.</p>\n </section>\n </div>","PeriodicalId":50679,"journal":{"name":"Clinical Implant Dentistry and Related Research","volume":"26 1","pages":"78-87"},"PeriodicalIF":3.7000,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cid.13288","citationCount":"0","resultStr":"{\"title\":\"A randomized, multicenter, double-blinded parallel study to evaluate the safety and performance of zoledronate-coated versus uncoated dental implants in partially edentulous patients\",\"authors\":\"Reza A. Mokhtari DDS, Morgan Olsson DDS, Per-Olov Östman DDS, Christer Dahlin DDS, PhD\",\"doi\":\"10.1111/cid.13288\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>To evaluate patient safety, implants survival and implant stability of the bisphosphonate (zoledronate) as a coating on dental implants in patients requiring oral rehabilitation in the posterior maxilla.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>In this multicenter, double-blind, randomized controlled study, 62 patients were randomized to receive either zoledronate-coated or uncoated control implants in the premolar or molar area of the maxilla, using a one stage-protocol. Due to dropouts and exclusion 49 patients completed the study. The implants were examined by resonance frequency analysis (RFA) using an implant stability quotient (ISQ) scale at the time of insertion, and at 8 weeks, and after 12 weeks prior to prosthetic restoration. Radiographs were taken prior to surgery, directly after insertion, and during the follow-up at 12 weeks, 6 months, and 1 year to analyze changes in marginal bone levels (MBL). Finally, all complications and adverse effects (AE) were observed and recorded.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Out of 62 included patients, 49 patients completed the study. No AE were reported by patients receiving zoledronate-coated implants. There was no statistically significant difference between the zoledronate-coated or uncoated implant groups when comparing ISQ levels at insertion and after 12 weeks of healing, the mean of the ISQ values demonstrated a change of 4.64 (95% confidence interval: 15.46; 5.79, <i>p</i> = 0.43) between the two groups. At 8- and 12-weeks, ISQ values remained stable (range 62–70). Radiographic analysis showed no statistically significant difference in MBL between the two implant groups after 1 year of loading neither at the mesial side (<i>p</i> = 0.99) or the distal side (<i>p</i> = 0.97). MBL for coated implants were 0.57 mm at the mesial side and 0.46 mm at the distal side. For the uncoated implants, MBL was 0.48 mm at the mesial side and 0.47 mm at the distal side.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>The zoledronate-coated dental implants are safe to use in a one-stage surgery protocol in patients requiring oral rehabilitation in the posterior maxilla, after 1 year of loading. There were no statically significant changes in implant stability and marginal bone levels measured by intraoral radiographs in comparison to uncoated control implants.</p>\\n </section>\\n </div>\",\"PeriodicalId\":50679,\"journal\":{\"name\":\"Clinical Implant Dentistry and Related Research\",\"volume\":\"26 1\",\"pages\":\"78-87\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2023-10-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cid.13288\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Implant Dentistry and Related Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/cid.13288\",\"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":"Clinical Implant Dentistry and Related Research","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/cid.13288","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}
A randomized, multicenter, double-blinded parallel study to evaluate the safety and performance of zoledronate-coated versus uncoated dental implants in partially edentulous patients
Objective
To evaluate patient safety, implants survival and implant stability of the bisphosphonate (zoledronate) as a coating on dental implants in patients requiring oral rehabilitation in the posterior maxilla.
Materials and Methods
In this multicenter, double-blind, randomized controlled study, 62 patients were randomized to receive either zoledronate-coated or uncoated control implants in the premolar or molar area of the maxilla, using a one stage-protocol. Due to dropouts and exclusion 49 patients completed the study. The implants were examined by resonance frequency analysis (RFA) using an implant stability quotient (ISQ) scale at the time of insertion, and at 8 weeks, and after 12 weeks prior to prosthetic restoration. Radiographs were taken prior to surgery, directly after insertion, and during the follow-up at 12 weeks, 6 months, and 1 year to analyze changes in marginal bone levels (MBL). Finally, all complications and adverse effects (AE) were observed and recorded.
Results
Out of 62 included patients, 49 patients completed the study. No AE were reported by patients receiving zoledronate-coated implants. There was no statistically significant difference between the zoledronate-coated or uncoated implant groups when comparing ISQ levels at insertion and after 12 weeks of healing, the mean of the ISQ values demonstrated a change of 4.64 (95% confidence interval: 15.46; 5.79, p = 0.43) between the two groups. At 8- and 12-weeks, ISQ values remained stable (range 62–70). Radiographic analysis showed no statistically significant difference in MBL between the two implant groups after 1 year of loading neither at the mesial side (p = 0.99) or the distal side (p = 0.97). MBL for coated implants were 0.57 mm at the mesial side and 0.46 mm at the distal side. For the uncoated implants, MBL was 0.48 mm at the mesial side and 0.47 mm at the distal side.
Conclusion
The zoledronate-coated dental implants are safe to use in a one-stage surgery protocol in patients requiring oral rehabilitation in the posterior maxilla, after 1 year of loading. There were no statically significant changes in implant stability and marginal bone levels measured by intraoral radiographs in comparison to uncoated control implants.
期刊介绍：
The goal of Clinical Implant Dentistry and Related Research is to advance the scientific and technical aspects relating to dental implants and related scientific subjects. Dissemination of new and evolving information related to dental implants and the related science is the primary goal of our journal.
The range of topics covered by the journals will include but be not limited to:
New scientific developments relating to bone
Implant surfaces and their relationship to the surrounding tissues
Computer aided implant designs
Computer aided prosthetic designs
Immediate implant loading
Immediate implant placement
Materials relating to bone induction and conduction
New surgical methods relating to implant placement
New materials and methods relating to implant restorations
Methods for determining implant stability
A primary focus of the journal is publication of evidenced based articles evaluating to new dental implants, techniques and multicenter studies evaluating these treatments. In addition basic science research relating to wound healing and osseointegration will be an important focus for the journal.
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