Wennström Jan L, Lindhe Jan
Department of Periodontology, Institute of Odontology, Göteborg University, Sweden.
J Clin Periodontol. 2002 Jan;29(1):9-14. doi: 10.1034/j.1600-051x.2002.290102.x.
The aim of the present study was to evaluate by clinical means the effect of enamel matrix proteins on the healing of a soft tissue wound produced by periodontal pocket instrumentation.
The study was performed as an intra-individual, longitudinal trial of 3 weeks duration with a double-masked, split-mouth, placebo-controlled and randomized design. The patient material was comprised of 28 subjects with moderately advanced, chronic periodontitis. Each patient presented with 3 sites in each of 2 jaw quadrants with a probing pocket depth (PPD) of >or=5 mm and bleeding following pocket probing (BoP). Baseline examination, including assessments of plaque, gingival inflammation, PPD, BoP and root dentin sensitivity, was carried out one week after oral hygiene instruction and careful self-performed plaque control. All experimental sites were scaled and root planed, and the soft tissue wall of the pocket was curetted to remove the pocket epithelium and adjacent granulation tissue. The site was carefully irrigated with saline. When the bleeding from the pocket had ceased, a 24% EDTA gel was applied in the site and retained for 2 min. This was followed by careful irrigation with saline. Left and right jaw quadrants were then randomized to subgingival application of enamel matrix derivative (Emdogain) or vehicle-control. All sites were re-examined after 1, 2 and 3 weeks. In addition, a visual analogue scale (VAS) was used to score the degree of post-treatment discomfort. The primary endpoints of treatment success were defined as (i) pocket closure (PPD <or=4 mm), (ii) no bleeding following pocket probing, (iii) no sign of gingival inflammation (GI score =0) and (iv) low degree of post-treatment discomfort (VAS <or=20). Statistical analyzes of intra-individual differences between the test and control treatments were performed by the use of Wilcoxon signed rank test. For comparison of the proportions of sites reaching the defined endpoints of treatment success, a site-based analysis was performed using 2x2 tables and the Fisher exact test.
The endpoint "GI score =0" was reached at 16% of the sites subjected to application of Emdogain at 1 week and at 2% of the control sites (p=0.001). At 2 weeks, the corresponding figures were 25% versus 12% (p =0.028). Absence of BoP was at 1 week 57% for the Emdogain treated sites compared to 35% for the control sites (p=0.003). At 2 weeks, this endpoint was reached in 73% and 59% of the test and control sites, respectively (p=0.051). In terms of the endpoint defined for probing pocket depth, PPD <or=4 mm, no differences between test and control sites were found. At 1 week, the proportion of patients reporting a VAS score <or=20 was significantly higher for the Emdogain treated quadrants than for controls (p=0.002).
The results indicated that Emdogain topically applied in instrumented pockets enhance the early healing of periodontal soft tissue wounds.
本研究旨在通过临床手段评估釉基质蛋白对牙周袋器械操作所致软组织伤口愈合的影响。
本研究采用个体内纵向试验,为期3周,采用双盲、分口、安慰剂对照和随机设计。患者材料包括28例中度晚期慢性牙周炎患者。每位患者在2个颌骨象限中的每个象限有3个部位,探诊袋深度(PPD)≥5 mm,探诊后出血(BoP)。在口腔卫生指导和患者自行认真控制菌斑1周后进行基线检查,包括对菌斑、牙龈炎症、PPD、BoP和根面牙本质敏感性的评估。所有试验部位均进行刮治和根面平整,刮除牙周袋软组织壁以去除袋上皮和相邻的肉芽组织。用盐水小心冲洗该部位。当袋内出血停止后,在该部位涂抹24%的乙二胺四乙酸(EDTA)凝胶并保留2分钟。随后用盐水小心冲洗。然后将左右颌骨象限随机分为龈下应用釉基质衍生物(Emdogain)或赋形剂对照。在1、2和3周后对所有部位进行复查。此外,使用视觉模拟量表(VAS)对治疗后不适程度进行评分。治疗成功的主要终点定义为:(i)袋闭合(PPD≤4 mm),(ii)探诊后无出血,(iii)无牙龈炎症迹象(牙龈炎症评分=0),(iv)治疗后不适程度低(VAS≤20)。采用Wilcoxon符号秩检验对试验组和对照组治疗的个体内差异进行统计分析。为比较达到治疗成功定义终点的部位比例,使用2×2表格和Fisher精确检验进行基于部位的分析。
在1周时,应用Emdogain的部位有16%达到“牙龈炎症评分=0”的终点,而对照部位为2%(p=0.001)。在2周时,相应数字分别为25%和12%(p =0.028)。在1周时,Emdogain治疗部位无BoP的比例为57%,而对照部位为35%(p=0.003)。在2周时,试验组和对照组分别有73%和59%的部位达到该终点(p=0.051)。就定义的探诊袋深度终点PPD≤4 mm而言,试验组和对照组部位之间未发现差异。在1周时,Emdogain治疗象限报告VAS评分≤20的患者比例显著高于对照组(p=0.002)。
结果表明,在器械操作后的牙周袋中局部应用Emdogain可促进牙周软组织伤口的早期愈合。