Lorenz Jonas, Ghanaati Shahram, Aleksic Zoran, Milinkovic Iva, Lazic Zoran, Magić Marko, Wessing Bastian, Grotenclos Ramona Schleich, Merli Mauro, Mariotti Giorgia, Bressan Eriberto, De Stavola Luca, Sader Robert
FORM-Frankfurt Orofacial Regenerative Medicine, Clinic for Oral, Cranio-Maxillofacial and Facial Plastic Surgery, Medical Center of the Goethe University Frankfurt, Frankfurt am Main, Germany.
Department of Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.
Clin Oral Implants Res. 2025 Jan;36(1):100-116. doi: 10.1111/clr.14363. Epub 2024 Oct 1.
Assess whether horizontal ridge augmentation with guided bone regeneration (GBR) using deproteinized bovine bone mineral (DBBM), autologous bone, and a resorbable collagen membrane supports successful implant placement.
This open, prospective, single-cohort, multicenter clinical study included patients with ridge defects that required GBR prior to implant insertion. The primary endpoint was radiologically assessed bone gain after 8 months post-GBR, measured at the center of planned implant sites. Secondary endpoints included implant survival and success, marginal bone levels (MBLs), MBL changes, and soft tissue health.
Of 45 patients evaluated 8 months post-GBR, nine experienced dehiscence in the first 3 weeks of the healing period. GBR led to radiologically determined mean bone width gain of 4.0 ± 1.5 mm and 4.8 ± 1.7 mm, measured 1 and 3 mm from the top of the crest, respectively, allowing successful implant placement in 44 patients (97.8%). The cumulative implant survival and success rates were 98.9% and 95.5%, respectively. MBLs were stable: -1.18 ± 0.64 mm at definitive prosthesis placement (DPP) and - 1.07 ± 0.74 mm at 1 year. Soft tissue health and esthetics (plaque and bleeding indices, papilla, keratinized mucosa, and pink esthetic score) improved from DPP to 1 year. Patients were highly satisfied with implant function and esthetics, and their oral health-related quality of life improved.
GBR using DBBM and a collagen membrane offered a safe and effective treatment option for horizontal ridge augmentation sufficient to support implant-based tooth rehabilitation.
Registered at ClinicalTrials.gov NCT03028922 (registrations sites, as above listed affiliations, first posted January 23, 2017).
评估使用脱蛋白牛骨矿物质（DBBM）、自体骨和可吸收胶原膜的引导骨再生（GBR）进行水平骨嵴增量是否能支持成功植入种植体。
这项开放性、前瞻性、单队列、多中心临床研究纳入了在植入种植体前需要进行GBR的骨嵴缺损患者。主要终点是在GBR后8个月通过影像学评估在计划种植部位中心测量的骨增量。次要终点包括种植体存活和成功情况、边缘骨水平（MBL）、MBL变化以及软组织健康状况。
在GBR后8个月评估的45例患者中，9例在愈合期的前3周出现裂开。GBR导致影像学测定的平均骨宽度增加，在距嵴顶1 mm和3 mm处分别为4.0±1.5 mm和4.8±1.7 mm，44例患者（97.8%）得以成功植入种植体。种植体的累积存活率和成功率分别为98.9%和95.5%。MBL稳定：在最终修复体就位（DPP）时为-1.18±0.64 mm，在1年时为-1.07±0.74 mm。从DPP到1年，软组织健康和美观情况（菌斑和出血指数、龈乳头、角化黏膜和粉色美学评分）有所改善。患者对种植体功能和美观高度满意，其口腔健康相关生活质量得到改善。
使用DBBM和胶原膜的GBR为水平骨嵴增量提供了一种安全有效的治疗选择，足以支持基于种植体的牙齿修复。
在ClinicalTrials.gov注册，注册号为NCT03028922（注册地点为上述列出的附属机构，首次发布于２０１７年１月２３日） 。
