Sculean A, Donos N, Blaes A, Lauermann M, Reich E, Brecx M
Department of Periodontology and Conservative Dentistry, University of the Saarland, Homburg, Germany.
J Periodontol. 1999 Mar;70(3):255-62. doi: 10.1902/jop.1999.70.3.255.
Enamel matrix proteins (EMP) have recently been introduced as a new modality for regenerative periodontal treatment. However, limited information is available concerning the comparison of the treatment of intrabony periodontal defects with enamel matrix proteins and other regenerative treatment alternatives.
The aim of the present controlled clinical trial was to compare the treatment of deep intrabony periodontal defects with EMP to that with guided tissue regeneration (GTR) with bioabsorbable membranes. Sixteen patients, each of whom displayed one pair of intrabony defects located contralaterally in the same jaw, were randomly treated with EMP or with a bioabsorbable membrane. Prior to surgery and 8 months later the following parameters were evaluated by a blinded examiner: Plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). Antibiotics (amoxicillin and metronidazole) were given during the first 10 days after surgery. No statistical significant differences in any of the investigated parameters between the 2 groups were observed at baseline.
No serious adverse events (e.g., allergic reactions or abscesses) after any of the treatments were noted during the entire observation period. Membrane exposure occurred in 7 out of the 16 GTR treated sites. Clinical examination was performed again 8 months postoperatively. Sites treated with EMP demonstrated a reduction of PD from 8.1+/-1.7 mm to 4.3+/-1.2 mm (P <0.001) and a change in CAL from 10.3+/-1.8 mm to 7.2+/-1.2 mm (P <0.001). The sites treated with GTR showed a reduction of PD from 8.3+/-1.7 mm to 4.3+/-0.7 mm (P <0.001) and a change of CAL from 10.1+/-1.9 mm to 7.1+/-1.7 mm (P <0.001). Both treatment procedures led to significant improvements of PD and CAL. However, no statistically significant differences in any of the investigated parameters were observed between the test and control group.
It may be concluded that both therapies led to shortterm improvements of the investigated clinical parameters. Further studies of much higher power are needed to support equivalence.
牙釉质基质蛋白（EMP）最近已被引入作为牙周再生治疗的一种新方法。然而，关于牙釉质基质蛋白治疗骨内牙周缺损与其他再生治疗方法的比较，可用信息有限。
本对照临床试验的目的是比较用EMP治疗深骨内牙周缺损与用可吸收生物膜引导组织再生（GTR）治疗的效果。16名患者，每人在同一颌骨的对侧有一对骨内缺损，被随机分为接受EMP治疗或可吸收生物膜治疗。在手术前和8个月后，由一位不知情的检查者评估以下参数：菌斑指数（PI）、牙龈指数（GI）、探诊出血（BOP）、探诊深度（PD）、牙龈退缩（GR）和临床附着水平（CAL）。在手术后的前10天给予抗生素（阿莫西林和甲硝唑）。两组在基线时，所调查的任何参数均未观察到统计学上的显著差异。
在整个观察期内，未注意到任何治疗后有严重不良事件（如过敏反应或脓肿）。16个接受GTR治疗的部位中有7个发生了膜暴露。术后8个月再次进行临床检查。接受EMP治疗的部位，PD从8.1±1.7mm降至4.3±1.2mm（P<0.001），CAL从10.3±1.8mm变为7.2±1.2mm（P<0.001）。接受GTR治疗的部位，PD从8.3±1.7mm降至4.3±0.7mm（P<0.001），CAL从10.1±1.9mm变为7.1±1.7mm（P<0.001）。两种治疗方法均使PD和CAL有显著改善。然而，试验组和对照组在所调查的任何参数上均未观察到统计学上的显著差异。
可以得出结论，两种疗法均使所调查的临床参数有短期改善。需要进一步进行更高效能的研究来支持等效性。
