B. M. Vetromilla, Guilherme Ferreira da Silva, Victório Poletto Neto, Antônio César Manentti Fogaça, T. P. Cenci
{"title":"与窦底抬高相关的短植入物与标准植入物:一项随机对照试验","authors":"B. M. Vetromilla, Guilherme Ferreira da Silva, Victório Poletto Neto, Antônio César Manentti Fogaça, T. P. Cenci","doi":"10.5335/rfo.v26i1.12327","DOIUrl":null,"url":null,"abstract":"Objective: the present equivalence two-arm parallel randomized controlled trial aimed to compare survival and marginal bone loss (MBL) of short implants (≤6 mm) and standard implants (≥8.5 mm) associated with sinus floor elevation (SFE). Methods: adult patients with partial edentulism with occlusal stability in the sinus area and intermediate bone height were selected in this double-blind trial (patient and outcome assessment). Patients were randomly allocated into two groups: standard length implants with SFE (control) or short implants (test). Clinical and radiographic assessments were made at the time of implant placement, 6 months, and annually thereafter up to 2 years after loading. The inter-examiner agreement was analyzed using intraclass correlation coefficient (ICC). One-way ANOVA, Kaplan-Meier, and Log-rank tests were used to compare implant survival (primary outcome) and MBL (secondary outcome) (P<0.05). Results: eight short implants and six standard implants were placed (mean age of patients was 47 ±12.5 years). The implant survival rates were 87.5% for short (one 5 mm implant failed at 7 months) and 100% for standard implants with no statistically significant difference between groups (P=0.4). The mean MBL after 1 year was 0.30 ±0.62 mm for short and 0.21 ±0.36 mm for standard implants (P=0.123). The inter-examiner agreement was set in 0.831. Conclusion: survival of short implants and standard implants associated with SFE was similar after two years of clinical service. Trial registration: Registered on 27-03-2018 at ClinicalTrials.gov (NCT03479333). Funding: This study was partially funded by Capes Finance Code 001 and #88881.187933/2018-01. TPC is partially funded by National Council for Scientific and Technological Development (CNPq - Brazil). The funders had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript.Keywords: bone resorption; dental implants; sinus floor augmentation; survival.","PeriodicalId":320919,"journal":{"name":"Revista da Faculdade de Odontologia - UPF","volume":"486 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Short vs standard implants associated with sinus floor elevation: a randomized controlled trial\",\"authors\":\"B. M. Vetromilla, Guilherme Ferreira da Silva, Victório Poletto Neto, Antônio César Manentti Fogaça, T. P. Cenci\",\"doi\":\"10.5335/rfo.v26i1.12327\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective: the present equivalence two-arm parallel randomized controlled trial aimed to compare survival and marginal bone loss (MBL) of short implants (≤6 mm) and standard implants (≥8.5 mm) associated with sinus floor elevation (SFE). Methods: adult patients with partial edentulism with occlusal stability in the sinus area and intermediate bone height were selected in this double-blind trial (patient and outcome assessment). Patients were randomly allocated into two groups: standard length implants with SFE (control) or short implants (test). Clinical and radiographic assessments were made at the time of implant placement, 6 months, and annually thereafter up to 2 years after loading. The inter-examiner agreement was analyzed using intraclass correlation coefficient (ICC). One-way ANOVA, Kaplan-Meier, and Log-rank tests were used to compare implant survival (primary outcome) and MBL (secondary outcome) (P<0.05). Results: eight short implants and six standard implants were placed (mean age of patients was 47 ±12.5 years). The implant survival rates were 87.5% for short (one 5 mm implant failed at 7 months) and 100% for standard implants with no statistically significant difference between groups (P=0.4). The mean MBL after 1 year was 0.30 ±0.62 mm for short and 0.21 ±0.36 mm for standard implants (P=0.123). The inter-examiner agreement was set in 0.831. Conclusion: survival of short implants and standard implants associated with SFE was similar after two years of clinical service. Trial registration: Registered on 27-03-2018 at ClinicalTrials.gov (NCT03479333). Funding: This study was partially funded by Capes Finance Code 001 and #88881.187933/2018-01. TPC is partially funded by National Council for Scientific and Technological Development (CNPq - Brazil). 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引用次数: 0
摘要
目的:目前的等效双臂平行随机对照试验旨在比较与窦底抬高(SFE)相关的短种植体(≤6mm)和标准种植体(≥8.5 mm)的生存和边缘骨丢失(MBL)。方法:采用双盲方法,选择牙槽区咬合稳定、骨高度中等的成年部分义齿患者(患者和结果评估)。患者被随机分为两组:标准长度的SFE种植体(对照)和短种植体(试验)。临床和影像学评估分别在植入时、植入后6个月和每年进行,直至植入后2年。使用类内相关系数(ICC)分析审查员间的一致性。采用单因素方差分析、Kaplan-Meier检验和Log-rank检验比较种植体存活(主要结局)和MBL(次要结局)(P<0.05)。结果:短种植体8枚,标准种植体6枚,患者平均年龄47±12.5岁。短种植体成活率为87.5%(7个月1个5mm种植体失败),标准种植体成活率为100%,组间差异无统计学意义(P=0.4)。短种植体1年后平均MBL为0.30±0.62 mm,标准种植体1年后平均MBL为0.21±0.36 mm (P=0.123)。审查员间协议设为0.831。结论:短种植体与标准种植体合并SFE的临床治疗后2年生存率相近。试验注册:于2018年3月27日在ClinicalTrials.gov注册(NCT03479333)。资金:本研究部分由Capes Finance Code 001和#88881.187933/2018-01资助。TPC部分由国家科学技术发展委员会(CNPq -巴西)资助。资助者在研究设计、数据收集和分析、决定发表或准备手稿方面没有任何作用。关键词:骨吸收;牙科植入物;窦底增强;生存。
Short vs standard implants associated with sinus floor elevation: a randomized controlled trial
Objective: the present equivalence two-arm parallel randomized controlled trial aimed to compare survival and marginal bone loss (MBL) of short implants (≤6 mm) and standard implants (≥8.5 mm) associated with sinus floor elevation (SFE). Methods: adult patients with partial edentulism with occlusal stability in the sinus area and intermediate bone height were selected in this double-blind trial (patient and outcome assessment). Patients were randomly allocated into two groups: standard length implants with SFE (control) or short implants (test). Clinical and radiographic assessments were made at the time of implant placement, 6 months, and annually thereafter up to 2 years after loading. The inter-examiner agreement was analyzed using intraclass correlation coefficient (ICC). One-way ANOVA, Kaplan-Meier, and Log-rank tests were used to compare implant survival (primary outcome) and MBL (secondary outcome) (P<0.05). Results: eight short implants and six standard implants were placed (mean age of patients was 47 ±12.5 years). The implant survival rates were 87.5% for short (one 5 mm implant failed at 7 months) and 100% for standard implants with no statistically significant difference between groups (P=0.4). The mean MBL after 1 year was 0.30 ±0.62 mm for short and 0.21 ±0.36 mm for standard implants (P=0.123). The inter-examiner agreement was set in 0.831. Conclusion: survival of short implants and standard implants associated with SFE was similar after two years of clinical service. Trial registration: Registered on 27-03-2018 at ClinicalTrials.gov (NCT03479333). Funding: This study was partially funded by Capes Finance Code 001 and #88881.187933/2018-01. TPC is partially funded by National Council for Scientific and Technological Development (CNPq - Brazil). The funders had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript.Keywords: bone resorption; dental implants; sinus floor augmentation; survival.