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一项评估天然骨矿物质与引导组织再生术治疗骨内缺损的前瞻性、随机、对照研究的五年结果。

Five-year results of a prospective, randomized, controlled study evaluating treatment of intra-bony defects with a natural bone mineral and GTR.

作者信息

Sculean Anton, Schwarz Frank, Chiantella Giovanni C, Donos Nikolaos, Arweiler Nicole B, Brecx Michel, Becker Jürgen

机构信息

Department of Periodontology, Radboud University Medical Center, Nijmegen, The Netherlands.

出版信息

J Clin Periodontol. 2007 Jan;34(1):72-7. doi: 10.1111/j.1600-051X.2006.01007.x.

DOI:10.1111/j.1600-051X.2006.01007.x
PMID:17243997
Abstract

BACKGROUND

Treatment with a natural bone mineral (NBM) and a guided tissue regeneration (GTR) has been shown to promote periodontal regeneration. However, until now there are only very limited data on the long-term clinical results following this regenerative technique.

AIM

To present the 5-year results of a prospective, randomized, controlled clinical study evaluating the treatment of deep intra-bony defects either with open flap debridement (OFD) and a combination of an NBM and GTR (test) or OFD alone (control).

METHODS

Nineteen patients diagnosed with advanced chronic periodontitis, and each of whom displayed one intra-bony defect, received randomly the test or the control treatment. Results were evaluated at baseline, at 1 and at 5 years following therapy.

RESULTS

No statistically significant differences in any of the investigated parameters were observed at baseline between the two groups. At 1 year after therapy, the test group showed a reduction in mean probing depth (PD) from 9.1+/-1.1 to 3.7+/-0.8 mm (p<0.001) and a change in mean clinical attachment level (CAL) from 10.4+/-1.3 to 6.4+/-1.2 mm (p<0.001). At 5 years, mean PD and CAL measured 4.3+/-0.8 and 6.7+/-1.6 mm, respectively. At 5 years, both PD and CAL were statistically significantly improved compared with baseline (p<0.001) without statistically significant differences between the 1- and 5-year results. In the control group, mean PD was reduced from 8.9+/-1.3 to 4.9+/-1.2 mm (p<0.001) and mean CAL changed from 10.6+/-1.4 to 8.8+/-1.5 mm (p<0.01). At 5 years, mean PD and CAL measured 5.6+/-1.1 and 9.1+/-1.3 mm, respectively, and were still statistically significantly improved compared with baseline (p<0.01). No statistically significant differences were found between the 1- and 5-year results. The test treatment, at both 1 and 5 years, yielded statistically significantly higher CAL gains than the control one (p<0.01). Compared with baseline, at 5 years a CAL gain of > or =3 mm was found in nine defects (90%) of the test group but in none of the defects treated with OFD alone.

CONCLUSIONS

It was concluded that (i) treatment of intra-bony defects with OFD+NBM+GTR may result in significantly higher CAL gains than treatment with OFD, and (ii) the clinical results obtained after both treatments can be maintained over a period of 5 years.

摘要

背景

天然骨矿物质(NBM)联合引导组织再生(GTR)治疗已被证明可促进牙周组织再生。然而,迄今为止,关于这种再生技术长期临床效果的数据非常有限。

目的

呈现一项前瞻性、随机、对照临床研究的5年结果,该研究评估了采用开放性翻瓣清创术(OFD)联合NBM与GTR(试验组)或单纯OFD(对照组)治疗重度骨内袋的效果。

方法

19例被诊断为重度慢性牙周炎且每人有一处骨内袋的患者被随机分配接受试验组或对照组治疗。在治疗前基线、治疗后1年和5年对结果进行评估。

结果

两组在基线时所研究的任何参数均无统计学显著差异。治疗后1年,试验组平均探诊深度(PD)从9.1±1.1mm降至3.7±0.8mm(p<0.001),平均临床附着水平(CAL)从10.4±1.3mm变为6.4±1.2mm(p<0.001)。5年时,平均PD和CAL分别为4.3±0.8mm和6.7±1.6mm。5年时,与基线相比,PD和CAL均有统计学显著改善(p<0.001),1年和5年结果之间无统计学显著差异。对照组平均PD从8.9±1.3mm降至4.9±1.2mm(p<0.001),平均CAL从10.6±1.4mm变为8.8±1.5mm(p<0.01)。5年时,平均PD和CAL分别为5.6±1.1mm和9.1±1.3mm,与基线相比仍有统计学显著改善(p<0.01)。1年和5年结果之间无统计学显著差异。试验组在1年和5年时的CAL改善均显著高于对照组(p<0.01)。与基线相比,5年时试验组9个骨内袋(90%)的CAL改善≥3mm,而单纯OFD治疗的骨内袋无此情况。

结论

得出如下结论:(i)与单纯OFD治疗相比,采用OFD+NBM+GTR治疗骨内袋可能导致CAL有显著更高的改善;(ii)两种治疗获得的临床效果在5年期间均可维持。

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