一项为期5年的随机试验,比较用于种植覆盖义齿的1枚或2枚种植体。

A 5-year randomized trial to compare 1 or 2 implants for implant overdentures.

作者信息

Bryant S R, Walton J N, MacEntee M I

机构信息

Division of Prosthodontics and Dental Geriatrics, Department of Oral Health Sciences, University of British Columbia, Canada

Division of Prosthodontics and Dental Geriatrics, Department of Oral Health Sciences, University of British Columbia, Canada.

出版信息

J Dent Res. 2015 Jan;94(1):36-43. doi: 10.1177/0022034514554224. Epub 2014 Oct 27.

Abstract

The hypothesis of this 5-y randomized clinical trial was that there would be no significant difference in the satisfaction of edentulous participants with removable complete overdentures attached to 1 or 2 mandibular implants. Secondary aims were to test changes in satisfaction between and within the groups from baseline to 5 y and differences between the groups in implant survival and prosthodontic maintenance over 5 y. Each of the 86 participants (mean age, 67 y) was randomly allocated to receive either 1 implant in the midline (group 1) or 2 implants in the canine areas (group 2) attached to a mandibular overdenture opposing a maxillary complete denture. Satisfaction was self-assessed by participants on a visual analog scale at baseline prior to implants, as well as at 2 mo and 1, 3, and 5 y with implant overdentures, whereas implant survival and prosthodontic maintenance were assessed by clinical examination. After 5 y, 29 participants in group 1 and 33 in group 2 were available, with most dropouts due to death. Satisfaction with the implant denture after 5 y was significantly (P < 0.001) higher than at baseline in both groups and remained with no significant difference (P = 0.32) between the groups. No implants failed in group 1 but 5 failed before loading in 4 participants in group 2. Most participants required maintenance or occasionally denture replacement, and although differences between the groups were not statistically significant, group 1 experienced almost twice as many fractured dentures usually adjacent to the implant attachment. We conclude that there were no significant differences after 5 y in satisfaction or survival of implants with mandibular overdentures retained by 1 implant or 2 implants. Additional research is required to confirm long-term treatment effectiveness of single-implant dentures and the implications of prosthetic maintenance with implant overdentures (ClinicalTrials.gov: NCT02117856).

摘要

这项为期5年的随机临床试验的假设是,佩戴附着于1颗或2颗下颌种植体的可摘全口覆盖义齿的无牙颌参与者的满意度不会有显著差异。次要目的是测试从基线到5年期间组间和组内满意度的变化,以及5年期间两组在种植体存留率和修复体维护方面的差异。86名参与者(平均年龄67岁)中的每一位都被随机分配接受以下两种治疗之一:在中线植入1颗种植体(第1组),或在尖牙区植入2颗种植体(第2组),并佩戴下颌覆盖义齿,与上颌全口义齿相对。参与者在植入种植体前的基线时,以及佩戴种植体覆盖义齿后的2个月、1年、3年和5年,通过视觉模拟量表进行自我满意度评估,而种植体存留率和修复体维护情况则通过临床检查进行评估。5年后,第1组有29名参与者,第2组有33名参与者,大多数退出是由于死亡。5年后两组对种植体义齿的满意度均显著高于基线水平(P<0.001),且两组之间仍无显著差异(P = 0.32)。第1组没有种植体失败,但第2组有4名参与者的5颗种植体在加载前失败。大多数参与者需要维护或偶尔更换义齿,尽管两组之间的差异无统计学意义,但第1组的义齿折断数量几乎是第2组的两倍,且折断通常发生在种植体附着部位附近。我们得出结论,5年后,由1颗种植体或2颗种植体支持的下颌覆盖义齿在满意度或种植体存留率方面没有显著差异。需要进一步的研究来证实单颗种植体义齿的长期治疗效果以及种植体覆盖义齿修复体维护的影响(ClinicalTrials.gov:NCT02117856)。

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