ObjectivesThis 5‐year multicenter randomized clinical trial assessed the non‐inferiority of maxillary implant‐supported fixed complete dentures (FCDs) with four (4‐I) compared to six implants (6‐I) in terms of radiographic marginal bone level (MBL) changes after 5 years in function.Materials and MethodsIndividuals were randomly assigned to the 4‐I or 6‐I groups. Follow‐ups occurred at 1, 3, and 5 years. At each visit, FCDs were unscrewed, clinical parameters (plaque index, bleeding on probing, pocket depth, and keratinized mucosa width) were recorded using a periodontal probe, periapical radiographs were obtained, and maintenance care was performed. MBL changes, incidence of techincal, prosthetic, and biological complications, treatments costs, and satisfaction were evaluated.ResultsOf 47 patients rehabiliated with 233 implants, survival rates were 99.3% for 6‐I and 100% for 4‐I (one early failure; 6‐I group). No significant MBL differences were observed at 5 years between and within the groups. Both groups showed a decrease in keratinized mucosa width and experienced prosthetic and biological complications, but no peri‐implantitis. The 4‐I exhibited a significantly higher incidence of technical complications (16.6% vs. 0%) Cost analysis favored 4‐I for initial and total costs. Clinician and patient satisfaction varied, with 4‐I preferred aesthetically and 6‐I functionally, particularly in speaking ability at earlier follow‐ups.ConclusionThe use of FCDs supported by four implants is non‐inferior to six implants in terms of radiographic MBL changes after 5 years in function. Both groups demonstrated comparable survival rates and incidence of biological and prosthetic complications. The 4‐I was associated with higher technical complications and reduced overall treatment cost.Trial RegistrationClinicalTrials.gov identifier: NCT02405169

中文翻译：

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由 4 个与 6 个种植体支持的固定全弓上颌修复体：一项多中心随机临床试验的 5 年结果


目的这项为期 5 年的多中心随机临床试验评估了 4 （4-I） 与 6 个种植体 （6-I） 相比，上颌种植体支持的固定全口义齿 （FCD） 在功能 5 年后影像学边缘骨水平 （MBL） 变化方面的非劣效性。材料和方法个体被随机分配到 4-I 或 6-I 组。随访发生在 1 、 3 和 5 年。每次就诊时，拧下 FCD，使用牙周探针记录临床参数 （斑块指数、探诊出血、牙周袋深度和角化粘膜宽度），获取根尖周围 X 线片，并进行维护护理。评估 MBL 变化、技术、修复和生物并发症的发生率、治疗费用和满意度。结果47 例植入 233 例植入物康复的患者，6-I 生存率为 99.3%，4-I 生存率为 100%（1 例早期失败;6-I 组）。5 年时，两组之间和组内未观察到显著的 MBL 差异。两组均显示角化粘膜宽度减少，并出现假体和生物并发症，但没有种植体周围炎。4-I 的技术并发症发生率显着更高 （16.6% vs. 0%） 成本分析有利于 4-I 的初始和总成本。临床医生和患者的满意度各不相同，4-I 更喜欢审美，6-I 更喜欢功能，尤其是在早期随访中的口语能力。结论就功能 5 年后影像学 MBL 变化而言，使用 4 个种植体支持的 FCD 不劣于 6 个种植体。两组的生存率以及生物和假体并发症的发生率相当。 4-I 与更高的技术并发症和降低的总体治疗成本相关。试验注册临床试验。gov 标识符：NCT02405169