Majid Omer Waleed
Professor, Department of Oral and Maxillofacial Surgery, College of Dentistry, Mosul University, Mosul, Iraq.
Evid Based Dent. 2024 Sep;25(3):127-128. doi: 10.1038/s41432-024-01059-7. Epub 2024 Aug 28.
A randomized, controlled, single-blind clinical trial.
To assess and compare patient-reported outcome measures (PROMs) between low-speed drilling without irrigation and high-speed drilling with irrigation for implant site preparation.
The study adhered to the Declaration of Helsinki principles, obtained approval from the local Ethics Committee, was registered on ClinicalTrials.gov, and was written in accordance with CONSORT guidelines. Included were adult patients with single posterior edentulism who exhibited good oral hygiene, sufficient bone dimensions for implant placement, adequate keratinized mucosa, stable occlusion, and a healthy periodontium. Patients were randomly assigned to either the test group (low-speed drilling (150 rpm) without irrigation) or the control group (high-speed drilling (800 rpm) with irrigation). A single dental implant was placed for each patient, with all surgeries conducted by the same experienced operator according to a standardized protocol. Patient satisfaction during surgery, including drilling-time perception, vibration, pressure, noise, comfort, and drowning sensation, as well as postoperative pain and inflammation, were assessed using a 100-mm visual analog scale. Quality of life (QOL) was evaluated using a 5-graded Likert scale for mouth opening, chewing, speaking, sleeping, daily routine, and job. Follow up extended on daily basis for 7 days. The PROMs were collected and analyzed in a blinded manner by independent researchers and a statistician to prevent bias.
The study included 66 patients (33 males and 33 females) with a mean age of 54.5 years. Patients in the test group reported a lower perception of drilling time, vibration, and noise but a higher perception of pressure compared to the control group; however, these differences were not statistically significant. Compared to the test group, patients in the control group experienced significantly greater drowning sensation and lesser comfort measures (p < 0.001). There was a moderate inverse correlation between drowning sensation and comfort (r = -0.57). The real drilling time was significantly longer in the test group compared to the control group (p < 0.001). The test group reported significantly lower pain levels during the first 12 h (p < 0.05), and significantly lower inflammation levels at the second day (p < 0.05) compared to the control group. No significant differences were observed between the groups at any time point for any of the QOL parameters (p > 0.05).
For a single implant site preparation, low-speed drilling without irrigation seems to offer greater patient comfort compared to high-speed drilling with irrigation, mainly due to reduced drowning sensation. Patients reported less postoperative pain and inflammation with the low-speed technique. Confirming these findings will require more research.
一项随机、对照、单盲临床试验。
评估并比较在种植位点预备时，不冲洗低速钻孔与冲洗高速钻孔两种方式下患者报告的结局指标（PROMs）。
本研究遵循赫尔辛基宣言原则，获得当地伦理委员会批准，在ClinicalTrials.gov上注册，并按照CONSORT指南撰写。纳入的成年患者为单后侧牙列缺失，口腔卫生良好，有足够的骨量用于种植体植入，有足够的角化黏膜，咬合稳定，牙周健康。患者被随机分为试验组（不冲洗低速钻孔（150转/分钟））或对照组（冲洗高速钻孔（800转/分钟））。为每位患者植入一枚牙种植体，所有手术均由同一位经验丰富的操作者按照标准化方案进行。使用100毫米视觉模拟量表评估手术过程中患者的满意度，包括对钻孔时间、振动、压力、噪音、舒适度和淹没感的感知，以及术后疼痛和炎症情况。使用5级李克特量表评估生活质量（QOL），涉及张口、咀嚼、说话、睡眠、日常生活和工作等方面。随访为期7天，每天进行。独立研究人员和统计学家以盲法收集和分析PROMs，以防止偏差。
该研究纳入66例患者（男性33例，女性33例），平均年龄54.5岁。试验组患者报告的钻孔时间、振动和噪音感知低于对照组，但压力感知高于对照组；然而，这些差异无统计学意义。与试验组相比，对照组患者的淹没感明显更强，舒适度更低（p<0.001）。淹没感与舒适度之间存在中度负相关（r=-0.57）。试验组的实际钻孔时间明显长于对照组（p<0.001）。试验组在术后前12小时的疼痛水平明显低于对照组（p<0.05），术后第二天的炎症水平也明显低于对照组（p<0.05）。在任何时间点，两组在任何生活质量参数方面均未观察到显著差异（p>0.05）。
对于单个种植位点的预备，与冲洗高速钻孔相比，不冲洗低速钻孔似乎能为患者提供更高的舒适度，主要是因为淹没感降低。患者报告低速技术术后疼痛和炎症更少。需要更多研究来证实这些发现。
