Mario Romandini^1,2,*; Andreina Laforí^3,4; Giacomo Baima⁵; Francesco Ferrarotti⁵; Cristina Lima¹; Lucrezia Paternó Holtzman⁶; Ignacio Pedrinaci¹; Mario Aimetti⁵; Mariano Sanz^1,2

¹Section of Graduate Periodontology, Faculty of Odontology; ²ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain; ³Department of Periodontology and Prosthodontics, “George Eastman” Dental Hospital, University Policlinic “Umberto I”, Rome, Italy; ⁴Division of Fixed Prosthodontics and Biomaterials, Clinic of Dental Medicine, University of Geneva, Geneva, Switzerland; ⁵Department of Surgical Sciences, C.I.R. Dental School, University of Turin, Turin; ⁶Department of Periodontology and Prosthodontics, “George Eastman” Dental Hospital, University Policlinic “Umberto I”, Rome, Italy

Background: Disease resolution represents only seldom the outcome of sub-mucosal instrumentation in the treatment of peri-implantitis, what makes the surgical therapy the gold standard approach in its moderate/severe forms. There is, therefore, a need for evidence demonstrating the added effect of sub-mucosal instrumentation before the surgical treatment of peri-implantitis, since this intermediary intervention involves longer treatment times, higher costs and increased discomfort for patients.

Aim/Hypothesis: The present multi-center randomized clinical trial with 12-months follow-up aimed at studying the added effect of sub-mucosal instrumentation before surgical treatment of moderate/severe peri-implantitis.

Material and Methods: Forty-two patients were recruited based on the diagnosis of moderate/severe peri-implantitis. After a behavioral intervention phase based on oral hygiene motivation and instructions, patients were randomized to either having supra- and sub-mucosal instrumentation on their affected implants (control group) or only supra-mucosal instrumentation (test group), before receiving surgery.

Clinical and radiographic variables were collected by blinded outcome-assessors. Probing pocket depth reduction with respect to baseline and treatment success criteria n.1 (no implant loss, no bone loss >0.5 mm, BoP/SoP- and PPD≤5 mm) at the 12-months examination were regarded as the primary outcomes of the trial.

Results: With the exception of a longer non-surgical treatment time in the control group (p < 0.001), no other studied outcome demonstrated statistically significant differences between groups.

Smoking status, Vitamin D intake, bone levels and suppuration at baseline, peri-implant phenotype and presence of plaque negatively influenced PPD reduction, while a positive effect was noted for KMH ≥2 mm, deepest PPD at baseline, reason of tooth loss, implant brand and surgical approach.

The presence of suppuration at baseline and of more than 3 sites with a PPD≥6 mm in the mouth other than study implants resulted associated with lower rates of treatment success, while the presence of severe periodontitis and of KMH ≥2 mm were associated with higher rates.

Conclusion and Clinical implications: The present findings question the value of non-surgical sub-mucosal instrumentation before surgical treatment of moderate/severe peri-implantitis.

Disclosure of Interest: None Declared

Keywords: clinical studies/trials, peri-implantitis

马里奥·罗曼迪尼^1,2,* ; 安德烈娜·拉福里^3,4 ; 贾科莫·白马⁵ ; 弗朗切斯科·费拉罗蒂⁵ ; 克里斯蒂娜·利马¹ ; 卢克雷齐娅·帕特诺·霍尔兹曼⁶ ; 伊格纳西奥·佩德里纳奇¹ ; 马里奥·艾梅蒂⁵ ; 马里亚诺·桑斯^1,2

¹牙医学院研究生牙周病学科；² ETEP（牙周病和种植体周围疾病的病因和治疗）研究组，西班牙马德里康普顿斯大学；³牙周病学和修复学系，“George Eastman”牙科医院，大学 Policlinic “Umberto I”，意大利罗马；⁴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；⁵都灵大学 CIR 牙科学院外科科学系，都灵；⁶牙周病学和修复学系，“George Eastman”牙科医院，大学 Policlinic “Umberto I”，意大利罗马

背景：疾病消退很少代表黏膜下器械治疗种植体周围炎的结果，这使得手术治疗成为中度/重度形式的金标准方法。因此，需要证据证明在种植体周围炎的手术治疗之前黏膜下器械的附加作用，因为这种中间干预涉及更长的治疗时间、更高的成本和增加患者的不适感。

目的/假设：本项具有 12 个月随访期的多中心随机临床试验旨在研究在手术治疗中度/重度种植体周围炎之前黏膜下器械的附加作用。

材料和方法：根据中度/重度种植体周围炎的诊断招募了 42 名患者。在基于口腔卫生动机和指示的行为干预阶段之后，在接受手术之前，患者被随机分配到在其受影响的植入物上使用黏膜上和黏膜下器械（对照组）或仅黏膜上器械（测试组）。

临床和放射学变量由不知情的结果评估者收集。在 12 个月的检查中，相对于基线和治疗成功标准n .1（无种植体丢失，无骨丢失 >0.5 mm，BoP/SoP-和 PPD≤5 mm）的探查袋深度减少被视为主要结果试用。

结果：除了对照组中较长的非手术治疗时间（p < 0.001）外，没有其他研究结果表明组间具有统计学显着差异。

吸烟状况、维生素 D 摄入量、基线骨水平和化脓、种植体周围表型和牙菌斑的存在对 PPD 减少产生负面影响，而 KMH ≥2 mm、基线最深 PPD、牙齿脱落原因、种植体则有积极影响品牌和手术方法。

基线时存在化脓以及口腔内 PPD ≥ 6 mm 的部位（除研究种植体外）的存在与较低的治疗成功率相关，而严重牙周炎和 KMH ≥ 2 mm 的存在与较高的治疗成功率相关。率。

结论和临床意义：目前的研究结果对中度/重度种植体周围炎手术治疗前非手术黏膜下器械的价值提出了质疑。

利益披露：无申报

关键词：临床研究/试验，种植体周围炎