Operative Times, Costs and Patient‐Related Outcome Measures in Vertical Ridge Augmentation With Customised Reinforced PTFE Mesh Versus CAD/CAM Titanium Mesh: Secondary Analysis of a Randomised Clinical Trial

IF 5.8 1区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE
Alessandro Cucchi, Sofia Bettini, Lucia Tedeschi, Debora Franceschi, Istvan Urban, Antonino Fiorino, Giuseppe Corinaldesi
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Abstract

AimThis secondary analysis of a randomised clinical trial aimed to investigate vertical ridge augmentation (VRA) by comparing complication rates (primary outcome), times, costs and patient‐reported outcome measures (PROMs) between customised Ti‐reinforced PTFE mesh and customised CAD/CAM titanium mesh.Materials and MethodsPatients with vertical bone defects were randomly assigned to alveolar bone augmentation using either Ti‐PTFE mesh or Ti mesh (T0). After 6–9 months, barriers were removed, and computer‐guided surgery was performed to place implants in the augmented sites (T1). Complications, times, costs and PROMs (anxiety, pain, anti‐inflammatory drug dosage, limitations in daily functions) were assessed and analysed.ResultsForty‐eight of 50 patients completed the bone augmentation surgery as per protocol. The estimated difference in healing complications was −0.04% (CI: −0.22 to 0.13), confirming the non‐inferiority of Ti meshes to PTFE meshes. The estimated differences were −3.50 min (CI: −23.49 to 16.49) for total operative time (p = 0.688); €17.37 (−77.25 to 111.99) for costs (p = 0.130); −0.17 (CI: −0.80 to 0.47) for anti‐inflammatory drug usage (p = 0.299); 0.56 (CI: −1.97 to 0.85) for pain levels (p = 0.565); and −0.13 (CI: −0.61 to 0.36) for limitations in daily functions (p = 0.528), on the day after surgery.ConclusionOutcomes were favourable, which encourage the use of both medical devices with low complication rates and both digital approaches, resulting in favourable operative times and PROMs.
定制增强聚四氟乙烯网与CAD/CAM钛网垂直嵴增强术的手术时间、成本和患者相关结果:一项随机临床试验的二次分析
目的:对一项随机临床试验进行二次分析,旨在通过比较定制的钛增强PTFE网片和定制的CAD/CAM钛网片之间的并发症发生率(主要结果)、时间、成本和患者报告的结果测量值(PROMs)来研究垂直脊增强(VRA)。材料和方法垂直骨缺损患者随机分配使用Ti - PTFE补片或Ti补片(T0)进行牙槽骨增强。6-9个月后,移除障碍,进行计算机引导手术,将植入物放置在增强部位(T1)。评估和分析并发症、时间、费用和PROMs(焦虑、疼痛、抗炎药物剂量、日常功能限制)。结果50例患者中48例按照方案完成了隆骨手术。愈合并发症的估计差异为- 0.04% (CI: - 0.22至0.13),证实Ti补片与PTFE补片相比没有劣效性。总手术时间的估计差异为- 3.50 min (CI: - 23.49 ~ 16.49) (p = 0.688);17.37欧元(- 77.25 - 111.99)的成本(p = 0.130);抗炎药物使用- 0.17 (CI: - 0.80至0.47)(p = 0.299);疼痛水平为0.56 (CI:−1.97 ~ 0.85)(p = 0.565);术后一天的日常功能限制为- 0.13 (CI: - 0.61至0.36)(p = 0.528)。结论采用两种低并发症的医疗器械和两种数字化入路,获得了良好的手术时间和prom。
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来源期刊
Journal of Clinical Periodontology
Journal of Clinical Periodontology 医学-牙科与口腔外科
CiteScore
13.30
自引率
10.40%
发文量
175
审稿时长
3-8 weeks
期刊介绍: Journal of Clinical Periodontology was founded by the British, Dutch, French, German, Scandinavian, and Swiss Societies of Periodontology. The aim of the Journal of Clinical Periodontology is to provide the platform for exchange of scientific and clinical progress in the field of Periodontology and allied disciplines, and to do so at the highest possible level. The Journal also aims to facilitate the application of new scientific knowledge to the daily practice of the concerned disciplines and addresses both practicing clinicians and academics. The Journal is the official publication of the European Federation of Periodontology but wishes to retain its international scope. The Journal publishes original contributions of high scientific merit in the fields of periodontology and implant dentistry. Its scope encompasses the physiology and pathology of the periodontium, the tissue integration of dental implants, the biology and the modulation of periodontal and alveolar bone healing and regeneration, diagnosis, epidemiology, prevention and therapy of periodontal disease, the clinical aspects of tooth replacement with dental implants, and the comprehensive rehabilitation of the periodontal patient. Review articles by experts on new developments in basic and applied periodontal science and associated dental disciplines, advances in periodontal or implant techniques and procedures, and case reports which illustrate important new information are also welcome.
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