这项研究的目的是比较患者报告的结果指标(PROMs)和在不同术后阶段用异种胶原基质(XCM)或游离牙龈移植物(FGG)增强后的临床结果。
纳入42例患者(每组21例),在后下颌骨的颊部植入部位角化粘膜宽度(KMW)<2mm。所有患者均接受前庭成形术,并分为FGG(对照组)或XCM(测试)组。术中疼痛的发病率,压力,恶心,对时间的宽容,手术后立即评估手术接受度。主观疼痛的严重程度和持续时间,肿胀,和出血在术后2周内进行比较。在6个月时评估了撤退的意愿和满意度。所有PROM均使用问卷调查和视觉模拟量表获得。还评估了口腔KMW和其他植入物周围参数。
手术后即刻观察到的PROM没有显著的组间差异,除了接受手术(0,0-30.0vs.30,0-50.0,p=0.025)。两周后,试验组的疼痛严重程度(46.7±25.9vs61.9±20.2,p=0.040)和持续时间(5.52±3.57vs8.48±2.80,p=0.005)显着降低,FGG在说话和咀嚼过程中的疼痛感知明显更高,在肿胀和出血方面没有显著的组间差异。6个月时,测试组表现出更高的撤退意愿(76%对43%,p=0.021);然而,两组患者对治疗结果的满意度相似.6个月时,FGG的KMW增益明显高于XCM(XCM:1.57±1.69mm,FGG:2.68±1.80mm,p=0.003)。其他种植体周围参数没有显着差异。
在当前非随机研究的限制下,XCM在术后不同阶段表现出比FGG更积极的PROM,主要是为了在早期愈合阶段减少疼痛感知,但在KMW的收益方面不如FGG。对于后下颌骨的KMW增强,当患者可以承受很小的疼痛时,可以使用XCM。
ChiCTR1900022575,注册日期:2019年4月17日,追溯注册。
The objective of this study was to compare patient-reported outcome measures (PROMs) and clinical outcomes after augmentation with xenogeneic collagen matrix (XCM) or free gingival graft (FGG) during different postoperative phases.
Forty-two patients (21 per group) with keratinized mucosa width (KMW) of < 2 mm at buccal implant sites in the posterior mandible were enrolled. All underwent vestibuloplasty and were allocated to either FGG (control) or XCM (test) group. Intraoperative morbidity of pain, stress, nausea, tolerance to time, and acceptance of surgery were evaluated immediately after surgery. The severity and duration of subjective pain, swelling, and bleeding were compared within a 2-week postoperative period. The willingness to retreat and satisfaction were assessed at 6 months. All PROMs were obtained using questionnaires and visual analog scales. The buccal KMW and other peri-implant parameters were also evaluated.
No significant between-group differences were observed in PROMs immediately after surgery, except acceptance of surgery (0, 0-30.0 vs. 30, 0-50.0, p = 0.025). At 2 weeks, pain severity (46.7 ± 25.9 vs 61.9 ± 20.2, p = 0.040) and duration (5.52 ± 3.57 vs 8.48 ± 2.80, p = 0.005) were significantly lower in the test group, and pain perception during speaking and chewing was significantly higher for FGG, with no significant between-group differences in swelling and bleeding. At 6 months, the test group showed a higher willingness to retreat (76% vs 43%, p = 0.021); however, satisfaction with treatment outcomes was similar in both groups. At 6 months, the gain of KMW was significantly higher in FGG than in XCM (XCM: 1.57 ± 1.69 mm, FGG: 2.68 ± 1.80 mm, p = 0.003). Other peri-implant parameters did not show significant differences.
Within the limitation of the present nonrandomized study, XCM demonstrated more positive PROMs than FGG during different postoperative phases, mainly for less pain perception during the early healing stage, but was inferior to FGG in terms of gain of KMW. For KMW augmentation in the posterior mandible, XCM may be indicated when patients can bear little pain.
ChiCTR1900022575 , date of registration: 17/4/2019, retrospectively registered.