The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant with the Transcrestal Sinus Floor Elevation Approach: A Randomized, Parallel CBCT Study.

Deniz Ozbay, Samet Tunc, Ahu Uraz Çörekci, Berceste Guler Ayyildiz, Serpil Cula
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Abstract

Purpose: To evaluate the clinical and radiographic results of simultaneous implant placement using transcrestal sinus floor elevation (TSFE) with and without enamel matrix derivative (EMD) application.

Materials and methods: Twenty-four patients were randomly assigned into two groups: The EMD+TSFE group (n = 13 patients, 20 implants) received TSFE with EMD application, and the TSFE group (n = 11 patients, 20 implants) received TSFE without EMD application. The patients were recalled at 3 (T3) and 12 (T12) months postsurgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), and implant stability (ISQ) were measured. Multivariate regressions were performed for the groups.

Results: At T3, the ESBG was 3.72 ± 0.85 mm in the EMD+TSFE group and 3.10 ± 0.05 mm in the TSFE group, and there were statistically significant differences (P < .05). However, there were no statistically significant differences in ESBG at T12 between the groups (P > .05). ISQ values did not show a statistical difference between the groups at T1 and T3, but at T3 in the TSFE+EMD group, there was a statistical increase in the intragroup evaluation compared to the TSFE group.

Conclusions: The use of EMD in TSFE procedures is effective in new bone formation at the apical part of the implant during the early healing period, but in the long term, no significant difference was shown between cases in which EMD was or was not used in terms of new bone formation and primary and secondary stabilization.

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釉质基质衍生物对经基底窦底提升法种植牙骨质再生潜力的评估:一项随机、平行设计的 CBCT 研究。
目的:该研究旨在评估应用和不应用釉质基质衍生物(EMD)的经基底窦底提升术(TSFE)同时植入种植体的临床和影像学效果:24名患者被随机分为两组:EMD+TSFE组定义为(13例患者,20颗种植体)应用EMD的TSFE,TSFE组定义为(11例患者,20颗种植体)不应用EMD的TSFE。患者分别在术后 3 个月(T3)和 12 个月(T12)进行复查。测量了残余骨高(RBH)、种植体突出长度(IPL)、种植体周围窦骨水平(SBL)、窦内骨增量(ESBG)和种植体稳定性(ISQ)。对各组进行了多变量回归:T3时,EMD+TSFE组的ESBG为3.72±0.85 mm,TSFE组的ESBG为3.10±0.05 mm,差异有统计学意义(P0.05)。(P0.05)ISQ值在T1和T3组间无统计学差异,但TSFE+EMD组在T3组内评估中与TSFE组相比有统计学增长:在这项研究中,可以说在 TSFE 操作中使用 EMD 在早期愈合期间对种植体根尖部分的新骨形成很有效,但从长期来看,在新骨形成和主要及次要稳定方面,使用或不使用 EMD 的病例之间没有显著差异。该研究已提交至 ClinicalTrials.com;临床试验编号为 ###。
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