Mandibular Overdentures on Four Immediately Loaded Mini-Implants Versus Two-Delayed Loaded Regular Implants: 1-Year, Two-Center RCT on Patient-Reported Outcomes

IF 5.9 1区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE
Clinical Oral Implants Research Pub Date : 2026-08-06 Epub Date: 2026-06-01 DOI:10.1111/clr.70143
Martin Schimmel, Cláudio Rodrigues Leles, Nicole Schenk, Simone F. M. Janner, Beat Wallkamm, Valérie G. A. Suter, Samir Abou-Ayash, Clemens Raabe
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引用次数: 0

Abstract

Objective

This one-year randomized clinical trial compared the effects of mandibular implant-overdentures (IODs) on two two-piece regular-neck tissue-level implants (Group A) or on four mini-implants (Group B) with different loading protocols in edentulous patients concerning dental Patient-Reported Outcomes (dPROs).

Material and Methods

Seventy-two participants were randomly assigned to Group A (n = 35) for treatment with two standard implants (3.3 mm diameter, conventional loading) with a stud-type abutment, or to Group B (n = 37) for treatment with four mini-implants (2.4 mm diameter, immediate loading) with a mini-stud-type abutment. Primary outcomes were measured using the General Oral Health Assessment Index (GOHAI), the 14-item Oral Health Impact Profile (OHIP-G14), and the Denture Satisfaction Index (DSI), at visit #1—baseline (pre-treatment), visit #2—implant placement (immediate loading, Group B), visit #3–8-10-week follow-up (conventional loading, Group A; control visit, Group B), and visit #4–1-year post-placement. Data analysis included descriptive statistics, non-parametric comparison tests, effect-size measures, and multiple regression.

Results

Sixty-two participants completed the 1-year follow-up (Group A = 32; Group B = 30). Significantly improved dPROs were observed for both treatments after 1 year, compared with baseline (p < 0.01), with similar effects in the two Groups. In the mini-implant group, higher improvement in satisfaction was observed after implant placement and immediate loading, compared to Group A (p < 0.001).

Conclusion

Significant improvements in satisfaction and Oral Health Related Quality of Life were observed after 1 year, and benefits were observed earlier for mini-implants using immediate loading. Overall, findings support the use of four immediately loaded mini-implants in the mandible as a suitable treatment alternative for edentulous patients.

Registration

ClinicalTrials.Gov ID: NCT03837158. https://clinicaltrials.gov/study/NCT03837158.

下颌覆盖义齿采用4个立即加载的微型种植体与2个延迟加载的常规种植体:患者报告的1年双中心随机对照试验结果。
目的:本研究是一项为期一年的随机临床试验,比较下颌种植覆盖义齿(IODs)对两种两件式常规颈部组织水平种植体(A组)和四种不同加载方案的微型种植体(B组)在无牙患者中对牙科患者报告预后(dPROs)的影响。材料和方法:72名参与者被随机分配到A组(n = 35),使用2个标准种植体(直径3.3 mm,常规加载)与钉型基台治疗,或B组(n = 37)使用4个微型种植体(直径2.4 mm,即时加载)与微型钉型基台治疗。主要结果采用一般口腔健康评估指数(GOHAI)、14项口腔健康影响量表(OHIP-G14)和义齿满意度指数(DSI),分别在第1次就诊(基线治疗前)、第2次就诊(即刻装填,B组)、第3-8-10周随访(常规装填,A组;对照组,B组)和第4-1年后就诊。数据分析包括描述性统计、非参数比较检验、效应量测量和多元回归。结果:62例患者完成1年随访(A组32例,B组30例)。结论:1年后,满意度和口腔健康相关生活质量均有显著改善,使用即时加载的微型种植体更早地观察到益处。总的来说,研究结果支持在下颌骨使用四个立即加载的微型种植体作为无牙患者的合适治疗选择。注册:临床试验。政府ID: NCT03837158。https://clinicaltrials.gov/study/NCT03837158。
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来源期刊
Clinical Oral Implants Research
Clinical Oral Implants Research 医学-工程:生物医学
CiteScore
7.70
自引率
11.60%
发文量
149
审稿时长
3 months
期刊介绍: Clinical Oral Implants Research conveys scientific progress in the field of implant dentistry and its related areas to clinicians, teachers and researchers concerned with the application of this information for the benefit of patients in need of oral implants. The journal addresses itself to clinicians, general practitioners, periodontists, oral and maxillofacial surgeons and prosthodontists, as well as to teachers, academicians and scholars involved in the education of professionals and in the scientific promotion of the field of implant dentistry.
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