Lucrezia Paterno Holtzman^1,*; Mario Romandini^2,3; Francesco Ferrarotti⁴; Andreina Laforì^5,6; Giacomo Baima⁴; Ignacio Pedrinaci⁷; Mario Aimetti⁴; Mariano Sanz^3,7; Luca Cordaro¹

¹Periodontology and Prosthodontics, Ospedale Odontoiatrico G. Eastman, "Umberto I" University Policlinic, Roma, Italy; ²Section of Graduate Periodontology, University Complutense; ³ETEP Research Group, Complutense University, Madrid, Spain; ⁴Department of Surgical Sciences, C.I.R Dental School, University of Turin, Turin; ⁵Periodontology and Prosthodontics, Ospedale Odontoiatrico G. Eastman, Roma, Italy; ⁶Division of Fixed Prosthodontics and Biomaterials, Clinic of Dental Medicine, University of Geneva, Geneva, Switzerland; ⁷Section of Graduate Periodontology, Complutense University, Madrid, Spain

Background: Surgical intervention of peri-implantitis is a commonly performed treatment for moderate/severe peri-implantitis and yields predictable results. Patient-reported outcome measures (PROMs) are gaining importance among the outcomes of interventional trials, however to date they have never been collected or investigated in the context of the surgical treatment of peri-implantitis.

Aim/Hypothesis: The aim of the present study is to describe the PROMs collected during and after the surgical treatment of moderate/severe peri-implantitis. The hypothesis is that the type of nonsurgical instrumentation completed before surgery will not influence the patient’s perception of the surgical procedure.

Material and Methods: The present study is a sub-analysis of a multicenter, randomized controlled clinical trial with a 12-month follow-up. Forty-two patients with moderate/severe peri-implantitis underwent surgical therapy of the affected implants previously treated by supra- and submucosal instrumentation (control group) or supramucosal instrumentation alone (test group). PROMs were collected at different time-points after surgery on 100 mm VAS scales. Perceived post-operative pain, swelling, bleeding and overall discomfort during surgery were recorded by the patients at the following time-points: immediately after surgery, 4-, 8-, 12- hours post-operatively and 1-, 2-, 3-, 4-, 5-, 6-, 7- and 14 days after the procedure. Patient perception of surgery was collected at a single time-point immediately after surgery. The number of analgesic tablets (paracetamol 500 mg) taken from days 0 to 7 post-surgery was recorded. Patients allergic to paracetamol were prescribed another appropriate analgesic.

Results: The average discomfort during surgery perceived by the patient was 31.70 ± 22.35. Pain immediately after surgery was 26.95 ± 19.88 on average and tended to increase after 4- and 8 hours (30.81 ± 22.12 and 33.04 ± 25.09, respectively). Average pain scores reached a minimum at 14 days (3.88 ± 8.08). Average swelling was 28.32 ± 19.52 immediately after surgery, increased to 29.98 ± 21.85 at 12 hours post-op and gradually decreased until day 14 (3.53 ± 7.80). Perceived bleeding was highest immediately after surgery (19.24 ± 16.56) and decreased steadily until day 14 (2.56 ± 7.41). Average paracetamol intake decreased steadily from day 0 (1.17 ± 1.09) until day 14 (0.34 ± 1.32), and 63.41% of patients took at least one tablet. Differences between groups (supramucosal alone versus supramucosal combined with submucosal) were not significant for the evaluated parameters at any of the time-points considered.

Conclusion and Clinical implications: The present study is the first to investigate PROMs in surgical treatment of moderate/severe peri-implantitis to the authors’ knowledge. Results suggest that perceived pain, swelling and bleeding are mild during the first 12 hours and can be controlled with one analgesic tablet on average. Symptoms decrease further in the following days. Additionally, the type of non-surgical instrumentation does not affect the patient’s perception of surgical treatment of peri-implantitis.

Disclosure of Interest: None Declared

Keywords: clinical studies/trials, patient satisfaction, peri-implantitis

卢克雷齐娅·帕特诺·霍尔兹曼^1,* ; 马里奥罗曼迪尼^2,3 ; 弗朗切斯科·费拉罗蒂⁴ ; 安德烈娜·拉弗利^5,6 ; 贾科莫·白马⁴ ; 伊格纳西奥·佩德里纳奇⁷ ; 马里奥·艾梅蒂⁴ ; 马里亚诺·桑斯^3,7 ; 卢卡科达罗¹

¹牙周病学和修复学，Ospedale Odontoiatrico G. Eastman，“Umberto I”大学医学院，罗马，意大利；²康普顿大学牙周病学专业；³西班牙马德里康普顿斯大学 ETEP 研究小组；⁴都灵大学 CIR 牙科学院外科科学系，都灵；⁵牙周病学和修复学，Ospedale Odontoiatrico G. Eastman，罗马，意大利；⁶瑞士日内瓦日内瓦大学牙科医学诊所固定修复和生物材料部；⁷西班牙马德里康普顿斯大学牙周病学研究生科

背景：种植体周围炎的手术干预是中度/重度种植体周围炎的常用治疗方法，可产生可预测的结果。患者报告的结果测量 (PROM) 在介入试验的结果中越来越重要，但迄今为止，它们从未在种植体周围炎的手术治疗中收集或研究过。

目的/假设：本研究的目的是描述在中度/重度种植体周围炎手术治疗期间和之后收集的 PROM。假设是手术前完成的非手术器械类型不会影响患者对手术过程的看法。

材料与方法：本研究是一项多中心、随机对照临床试验的子分析，随访时间为 12 个月。42 名中度/重度种植体周围炎患者接受了先前通过黏膜上和黏膜下器械（对照组）或单独黏膜上器械（试验组）治疗的受影响种植体的手术治疗。在 100 mm VAS 量表上在手术后的不同时间点收集 PROM。患者在以下时间点记录手术过程中感知到的术后疼痛、肿胀、出血和整体不适：手术后立即、术后 4、8、12 小时和 1、2、3 -、4-、5-、6-、7- 和 14 天后手术。在手术后立即在单个时间点收集患者对手术的感知。记录术后第 0 天至第 7 天服用的镇痛药片（扑热息痛 500 毫克）的数量。对扑热息痛过敏的患者开了另一种合适的镇痛药。

结果：患者在手术过程中感受到的平均不适感为 31.70 ± 22.35。手术后立即的疼痛平均为 26.95 ± 19.88，并在 4 小时和 8 小时后趋于增加（分别为 30.81 ± 22.12 和 33.04 ± 25.09）。平均疼痛评分在 14 天时达到最低 (3.88 ± 8.08)。手术后立即平均肿胀为 28.32 ± 19.52，术后 12 小时增加至 29.98 ± 21.85，并逐渐减少，直到第 14 天 (3.53 ± 7.80)。术后即刻感知到的出血量最高 (19.24 ± 16.56)，并在第 14 天前稳步下降 (2.56 ± 7.41)。从第 0 天 (1.17 ± 1.09) 到第 14 天 (0.34 ± 1.32)，平均对乙酰氨基酚摄入量稳步下降，63.41% 的患者至少服用了一片。

结论和临床意义：据作者所知，本研究是第一个研究 PROM 在中度/重度种植体周围炎手术治疗中的研究。结果表明，在最初的 12 小时内，感知到的疼痛、肿胀和出血是轻微的，平均可以用一片镇痛药片控制。在接下来的几天里，症状会进一步减轻。此外，非手术器械的类型不会影响患者对种植体周围炎手术治疗的看法。

利益披露：无申报

关键词：临床研究/试验，患者满意度，种植体周围炎