Conventional versus flap-protected free gingival graft: a multicenter randomized clinical trial

Abstract The purpose of this study was to compare the outcomes of a modified gingival graft technique, in which the released flap is positioned and sutured over the graft, with the conventional free gingival graft (FGG) procedure, when both are used for gingival augmentation. A 12-month, multicenter parallel randomized controlled trial was conducted. Subjects with buccal RT2 gingival recessions and keratinized tissue width (KTW) < 2 mm in at least one mandibular incisor were randomized to control group (n = 20; conventional FGG) or test group (n = 20; modified FGG; flap sutured over FGG using sling sutures). The primary outcome (KTW) was measured at baseline and after 3, 6 and 12 months, as was keratinized tissue thickness (KTT). Postoperative pain (POP) and analgesic intake were also recorded. Both techniques promoted a significant increase in KTW and KTT when compared to baseline (p < 0.05) with no significant differences between groups (KTW change of 6.1±1.5 mm and 5.4±1.6 mm, for control and test, respectively; p=0.16). However, test group patients reported less POP after 7 days and used less analgesic medication than control group patients (p < 0.05). We concluded that the modified FGG was comparable to conventional FGG in augmenting keratinized tissue width and thickness at mandibular incisors, but resulted in less patient morbidity.

摘要 本研究旨在比较改良式牙龈移植术（将游离后的组织瓣移位并缝合覆盖于移植物表面）与传统游离牙龈移植术（conventional free gingival graft, FGG）用于牙龈增量治疗的效果。本研究为一项为期12个月的多中心平行随机对照试验。纳入至少1颗下颌切牙存在颊侧RT2型牙龈退缩且角化组织宽度（KTW）＜2 mm的受试者，将其随机分为对照组（n=20，采用传统FGG术式）与试验组（n=20，采用改良FGG术式：以悬吊缝合将组织瓣固定覆盖于移植物表面）。于基线及术后3、6、12个月测量主要结局指标角化组织宽度（KTW），同时检测角化组织厚度（KTT）；此外记录术后疼痛（POP）与镇痛药物使用情况。与基线水平相比，两种术式均可显著提升KTW与KTT（p＜0.05），组间差异无统计学意义：对照组与试验组的KTW增量分别为6.1±1.5 mm与5.4±1.6 mm（p=0.16）。但试验组受试者术后7天内的术后疼痛程度更低，镇痛药物使用量也更少（p＜0.05）。本研究结论为，改良FGG术式在提升下颌切牙角化组织宽度与厚度方面与传统FGG术式效果相当，但可减轻患者术后不适反应。