Chen Jiaxian, Chen Zhenqi, Yan Qi, Yin Ruikang, Feng Yi, Wang Li
State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.
Department of Oral Implantology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.
BMC Oral Health. 2025 Jul 23;25(1):1233. doi: 10.1186/s12903-025-06560-8.
To evaluate patient-reported outcome measures (PROMs) of povidone-iodine rinse and chlorhexidine rinse for patients undergoing dental implant treatments, as well as their bacteriostatic efficacy.
Patients needing implant or bone augmentation surgery were randomized into two groups: povidone-iodine(PVP-I) and chlorhexidine(CHX). On the first day after surgery, pain levels were assessed by Numerical Rating Scale (NRS) to compare the two mouthwashes. At two weeks post-surgery, wound healing was evaluated using the early wound healing index. Finally, patient-reported outcome measures (PROMs) were employed to compare each mouthwash's flavor, texture, and whether it caused irritation or mucosal staining. The significance of intergroup differences was tested using both an intention to treat and a per-protocol analysis.
A total of 83 patients(with a median age of 43, 49 females) were enrolled and randomized. In general, both rinses were similarly favorable in terms of patient comfort. Notably, the postoperative pain NRS was significantly lower in the PVP-I group (1.68 ± 0.82) than in the control group (2.55 ± 1.38, p < 0.01). Regarding to wound healing, there was no significant difference in the Early Healing Index (EHI) between the two groups (Z = 0.351, p = 0.725). Regarding PROMs, at day 7, the swelling reduction was significantly greater in the PVP-I group (p = 0.031). Additionally, fewer participants in the PVP-I group (7%) reported mucosal irritation compared to the CHX group (29%) (p < 0.05), while other PROMs showed no significant differences in both groups.
Within the scope of this trial, PVP-I rinse demonstrated superior patient comfort (significantly lower postoperative pain intensity, less mucosal irritation, and greater swelling reduction at day 7) compared to CHX rinse, though both rinses showed comparable wound healing outcomes. PVP-I may serve as an alternative for dental implant therapy, but all mouthrinses should be used judiciously under clinical guidance.
The study protocol was registered at Chinese Clinical Trial Registry ( www.chictr.org.cn ) under registration number ChiCTR2500098491 on 10/03/2025 (retrospectively registered).
评估聚维酮碘漱口液和氯己定漱口液用于接受牙种植治疗患者的患者报告结局指标（PROMs）及其抑菌效果。
需要进行种植或骨增量手术的患者被随机分为两组：聚维酮碘（PVP-I）组和氯己定（CHX）组。术后第一天，采用数字评定量表（NRS）评估疼痛程度，以比较两种漱口液。术后两周，使用早期伤口愈合指数评估伤口愈合情况。最后，采用患者报告结局指标（PROMs）比较每种漱口液的味道、质地以及是否引起刺激或黏膜染色。采用意向性分析和符合方案分析检验组间差异的显著性。
共纳入83例患者（中位年龄43岁，女性49例）并进行随机分组。总体而言，两种漱口液在患者舒适度方面相似。值得注意的是，PVP-I组术后疼痛NRS显著低于对照组（1.68±0.82）（对照组为2.55±1.38，p<0.01）。关于伤口愈合，两组早期愈合指数（EHI）无显著差异（Z=0.351，p=0.725）。关于PROMs，在第7天，PVP-I组肿胀减轻更显著（p=0.031）。此外，PVP-I组报告黏膜刺激的参与者（7%）少于CHX组（29%）（p<0.05），而其他PROMs在两组中无显著差异。
在本试验范围内，与CHX漱口液相比，PVP-I漱口液在患者舒适度方面表现更优（术后疼痛强度显著更低、黏膜刺激更少且在第7天肿胀减轻更明显），尽管两种漱口液在伤口愈合结果方面相当。PVP-I可作为牙种植治疗的一种替代选择，但所有漱口液都应在临床指导下谨慎使用。
该研究方案于2025年3月10日在中国临床试验注册中心（www.chictr.org.cn）注册，注册号为ChiCTR2500098491（回顾性注册）。
