AimTo assess the impact of the timing of soft‐tissue augmentation (STA) on mean buccal bone changes following immediate implant placement (IPP) in the anterior maxilla.Materials and MethodsPatients with a failing tooth and intact buccal bone wall in the anterior maxilla (15–25) were enrolled in this randomized controlled trial. Following single IIP and socket grafting, they were randomly allocated to the control group (immediate STA performed during the same surgical procedure) or the test group (delayed STA performed 3 months later). Implants were placed with a surgical guide and immediately restored with an implant‐supported provisional crown. Changes in bone dimensions were assessed using superimposed CBCT images taken prior to surgery and at 1‐year follow‐up. Clinical outcomes were registered at 1‐year follow‐up.ResultsTwenty patients were randomized to each group (control: 16 females, 4 males, mean age 57.6; test: 9 females, 11 males, mean age 54.2). Ten patients in the control group and 13 patients in the test group had a thick bone wall phenotype. Estimated marginal mean horizontal buccal bone loss at 1 mm below the implant shoulder was −0.553 and −0.898 mm for the control and test group, respectively. The estimated mean difference of 0.344 mm in favour of the control group was not significant (95% CI: −0.415 to 1.104; p = 0.363). Also at all other horizontal and vertical levels, no significant differences could be observed between the groups. The combination of socket grafting and STA enabled counteraction of any buccal soft‐tissue loss (≥ 0 mm) at 1 mm below the implant shoulder in 82% of the patients in the control group and in 75% of the patients in the test group (p = 1.000). The clinical outcome was favourable in both groups, yet implants in the control group demonstrated slightly less marginal bone loss (median difference 0.20 mm; 95% CI: 0.00–0.44; p = 0.028).ConclusionIn patients with an intact and mainly thick buccal bone wall in the anterior maxilla, the timing of STA following IIP had no significant impact on mean buccal bone loss.Trial RegistrationClinicalTrials.gov identifier: NCT05537545

中文翻译：

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一项关于即刻种植体植入中软组织增强时间的随机对照试验：硬组织变化和临床结果


目的评估软组织增强 （STA） 的时间对上颌前牙立即种植体植入 （IPP） 后平均颊骨变化的影响。材料和方法上颌前牙衰竭且颊侧骨壁完整的患者 （15-25） 被纳入这项随机对照试验。在单个 IIP 和牙槽移植术后，他们被随机分配到对照组 （在同一手术过程中进行即刻 STA） 或测试组 （3 个月后进行延迟 STA）。种植体用手术导板放置，并立即使用种植体支撑的临时牙冠进行修复。使用手术前和 1 年随访时拍摄的叠加 CBCT 图像评估骨骼尺寸的变化。在 1 年随访时记录临床结果。结果每组 20 例患者被随机分配 （对照组：16 例女性，4 例男性，平均年龄 57.6 例;测试：9 例女性，11 例男性，平均年龄 54.2 例）。对照组 10 例患者和试验组 13 例患者具有厚骨壁表型。对照组和测试组在种植体肩部下方 1 mm 处估计的边缘平均水平颊骨丢失分别为 -0.553 和 -0.898 mm。有利于对照组的 0.344 mm 的估计平均差异不显著 （95% CI： -0.415 至 1.104;p = 0.363）。同样在所有其他水平和垂直水平上，组间没有观察到显著差异。牙槽移植和 STA 的结合能够在对照组中 82% 的患者和测试组中 75% 的患者抵消种植体肩部下方 1 mm 处的任何颊侧软组织损失 （≥ 0 mm） （p = 1.000）。 两组的临床结局均良好，但对照组种植体的边缘骨丢失略少（中位差异 0.20 mm;95% CI：0.00-0.44;p = 0.028）。结论在上颌前颊侧骨壁完整且主要较厚的患者中，IIP 后 STA 的时间对平均颊骨丢失没有显著影响。试验注册临床试验。gov 标识符：NCT05537545