Dental Research Division, School of Dentistry, Paulista University, São Paulo, Brazil.
Department of Oral Surgery and Stomatology, School of Dental Medicine, University of Bern, Bern, Switzerland.
Clin Implant Dent Relat Res. 2023 Jun;25(3):447-457. doi: 10.1111/cid.13202. Epub 2023 Mar 22.
This randomized controlled trial evaluated the impact of a partially exposed non-absorbable membrane (dPTFE) in Alveolar Ridge Preservation (ARP) procedures on clinical, tomographic, immunoenzymatic, implant-related, and patient-centered outcomes.
Patients with a hopeless maxillary single-rooted tooth demanding rehabilitation with implants were included. Patients were randomized into two groups: dPTFE (n = 22)-tooth extraction followed by ARP using a partially exposed dPTFE membrane; USH (n = 22)-unassisted socket healing. Clinical and tomographic analyses were performed at baseline and after 3 months. After 3 months, patients received one dental implant. Implant stability quotient was obtained following implant placement. Bone-related markers were analyzed in bone biopsies using an immunoenzymatic assay.
Greater gain in Keratinized Mucosa Width (KMW) was observed in the dPTFE (1.33 ± 0.98 mm) compared to USH (0.59 ± 0.98 mm) (Mann-Whitney test, Z = 2,28, p < 0.05). USH showed a reduction of pain/discomfort, edema, and interference with daily life from the seventh day (Friedman/Wilcoxon test, maxT = 7.48, 8.00, and 5.92, respectively, p < 0.05). dPTFE presents a reduction of edema and interference with daily life from the 7th day and pain/discomfort from the 14th day (Friedman/Wilcoxon test, maxT = 5.40, 5.26, and 4.78, respectively, p < 0.05). The dPTFE group presented higher pain/discomfort in the 35 and 42 days and higher edema from 7 to 42 days postoperatively than USH group (Mann-Whitney test, p < 0.05). No differences between groups were observed in the tomographic measures, immunoenzymatic analysis, and implant stability (p > 0.05).
dPTFE was superior to USH by increasing KMW gain. However, dPTFE without bone graft presented similar bone loss compared to USH. This clinical trial was not registered prior to participant recruitment and randomization (NCT04329351).
本随机对照试验评估了部分暴露不可吸收膜(dPTFE)在牙槽嵴保存(ARP)手术中对临床、影像学、免疫酶、种植体相关和以患者为中心的结果的影响。
纳入需要植入物修复的上颌单根无希望牙齿的患者。患者随机分为两组:dPTFE(n=22)-拔牙后使用部分暴露的 dPTFE 膜进行 ARP;USH(n=22)-非辅助窝愈合。基线和 3 个月后进行临床和影像学分析。3 个月后,患者接受一颗牙种植体。植入物放置后获得种植体稳定性商数。使用免疫酶测定法在骨活检中分析与骨相关的标志物。
与 USH(0.59±0.98mm)相比,dPTFE 组(1.33±0.98mm)角化黏膜宽度(KMW)增加更多(Mann-Whitney 检验,Z=2.28,p<0.05)。USH 组从第 7 天开始疼痛/不适、肿胀和日常生活干扰减少(Friedman/Wilcoxon 检验,maxT=7.48、8.00 和 5.92,分别,p<0.05)。dPTFE 组从第 7 天开始肿胀和日常生活干扰减少,从第 14 天开始疼痛/不适减少(Friedman/Wilcoxon 检验,maxT=5.40、5.26 和 4.78,分别,p<0.05)。dPTFE 组在第 35 天和第 42 天的疼痛/不适和术后第 7 天至第 42 天的肿胀均高于 USH 组(Mann-Whitney 检验,p<0.05)。两组在影像学测量、免疫酶分析和种植体稳定性方面无差异(p>0.05)。
dPTFE 通过增加 KMW 增加优于 USH。然而,无骨移植的 dPTFE 与 USH 相比,出现相似的骨丢失。本临床试验在招募参与者和随机分组之前未进行注册(NCT04329351)。