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一项开放性、前瞻性、非随机、对照、多中心研究,旨在评估60岁以上骨质疏松/骨量减少女性植入治疗的临床结果:1年结果

An open, prospective, non-randomized, controlled, multicentre study to evaluate the clinical outcome of implant treatment in women over 60 years of age with osteoporosis/osteopenia: 1-year results.

作者信息

Temmerman Andy, Rasmusson Lars, Kübler Alexander, Thor Andreas, Quirynen Marc

机构信息

Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.

Department of Oral and Maxillofacial Surgery, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

出版信息

Clin Oral Implants Res. 2017 Jan;28(1):95-102. doi: 10.1111/clr.12766. Epub 2016 Jan 7.

Abstract

BACKGROUND

Osteoporosis has been called a potential risk factor for bone healing around implants.

AIM

The aim of this multicentre study was to verify the clinical performance of fluoridated implants in the maxilla of subjects with diagnosed systemic primary osteoporosis/osteopenia.

MATERIAL AND METHODS

Postmenopausal women in need of 2-8 splinted implants in maxilla underwent bone mineral density measurements in the hip and spine, using dual-energy X-ray absorptiometry scans. Based on their T-scores, they were divided into two study groups: Group O (osteoporosis/osteopenia group) subjects had a T-score ≤-2, Group C (control group) had a T-score of ≥-1, and subjects with a T-score <-1 but >-2 were excluded. Implants were placed with a two-stage procedure and loaded 4-8 weeks after abutment surgery. At 6 months and 1 year after functional loading, clinical parameters (including peri-apical radiographs) were assessed.

RESULTS

One hundred and forty-eight implants were placed in 48 subjects (mean age: 67 years (range [59-83]). Sixty-three implants were placed in 20 osteoporosis subjects (Group O, mean age: 69 years; range [59-83]), and 85 were placed in control subjects (Group C, mean age: 65 years; range [60-74]). The cumulative survival rate, on an implant level, was 99.3% (Group O: 98.4%; Group C: 100.0%). The cumulative survival rate, on a subject level, was 97.9% (Group O: 94.7%; Group C: 100.0%). Marginal bone level (MBL) alterations from functional loading to the 1-year follow-up visit were measured on an implant level and a subject level. The overall MBL alteration on an implant level was -0.01 ± 0.51 mm (Group O: -0.11 ± 0.49 mm; Group C: 0.05 ± 0.52 mm). The overall MBL alteration on a subject level was -0.04 ± 0.27 mm (Group O: -0.17 ± 0.30 mm; Group C: 0.04 ± 0.23 mm).

CONCLUSION

Within the limitations of this prospective, non-randomized, controlled, multicentre study, it can be concluded that oral implant therapy in patients suffering from osteoporosis/osteopenia is a reliable treatment option with comparable integration rates as in healthy patients. Long-term follow of the study groups is necessary to compare marginal bone alterations and treatment outcomes.

摘要

背景

骨质疏松症被认为是种植体周围骨愈合的潜在危险因素。

目的

本多中心研究的目的是验证氟化种植体在已诊断为全身性原发性骨质疏松症/骨质减少症患者上颌骨中的临床性能。

材料与方法

需要在上颌骨植入2 - 8颗夹板式种植体的绝经后女性,使用双能X线吸收测定扫描法测量其髋部和脊柱的骨密度。根据她们的T值,将她们分为两个研究组:O组(骨质疏松症/骨质减少症组)受试者的T值≤ -2,C组(对照组)的T值≥ -1,T值< -1但> -2的受试者被排除。采用两阶段手术植入种植体,并在基台手术后4 - 8周进行加载。在功能加载后6个月和1年,评估临床参数(包括根尖周X线片)。

结果

48名受试者(平均年龄:67岁[范围59 - 83岁])共植入148颗种植体。20名骨质疏松症受试者(O组,平均年龄:69岁;范围[59 - 83岁])植入63颗种植体,对照组(C组,平均年龄:65岁;范围[60 - 74岁])植入85颗种植体。在种植体水平上,累积存活率为99.3%(O组:98.4%;C组:100.0%)。在受试者水平上,累积存活率为97.9%(O组:94.7%;C组:100.0%)。在种植体水平和受试者水平上测量从功能加载到1年随访期的边缘骨水平(MBL)变化。在种植体水平上,总体MBL变化为-0.01±0.51mm(O组:-0.11±0.49mm;C组:0.05±0.52mm)。在受试者水平上,总体MBL变化为-0.04±0.27mm(O组:-0.17±0.30mm;C组:0.04±0.23mm)。

结论

在这项前瞻性、非随机、对照、多中心研究的局限性内,可以得出结论,骨质疏松症/骨质减少症患者的口腔种植治疗是一种可靠的治疗选择,其整合率与健康患者相当。有必要对研究组进行长期随访,以比较边缘骨变化和治疗结果。

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