Peri-Implant Mucositis Treatment with a Chlorexidine Gel with A.D.S. 0.5%, PVP-VA and Sodium DNA vs a Placebo Gel: A Randomized Controlled Pilot Clinical Trial.

Felice Lorusso, Gianluca Tartaglia, Francesco Inchingolo, Antonio Scarano
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引用次数: 1

Abstract

Background: Peri-implant mucositis is a bacterial and inflammatory disease of implant surrounding soft tissues. Chlorhexidine (CHX) associated with PVP-VA (Polyvinylpyrrolidone/vinyl acetate) has an adjuvant function in the antibacterial activity: it protects the film-forming layer, due to polymer, from microbial contamination or over-infection, and prolongs its permanence, without a direct action on the tissues and wounds. Sodium DNA is able to improve gingival trophism. The aim of the study was to compare a gel with CHX and antidiscoloration system (A.D.S.) 0.5% with the addition of PVP-VA and sodium DNA with a placebo gel without chlorexidine in peri-implant mucositis treatment.

Methods: Trial design: A single center randomized controlled pilot clinical trial was conducted on a total of 24 patients with mucositis, randomly allocated into two groups. In the group (A) (n = 12) patients were treated with a gel with CHX + A.D.S. 0.5% while a placebo gel was used in the group (B) (n = 12).

Outcome: Plaque Index (PI) (primary outcome), Bleeding on probing (BOP) and Gingival Index (GI) (secondary outcomes) were assessed at baseline and at 2 weeks after treatment period.

Results: Mean PI score recorded at baseline was 2.4 ± 0.4 [95% CI: -2.682/7.482] in the group (A) and 2.2 ± 0.5 [95% CI: -4.153/8.553] in the group (B) (p > 0.05) while mean PI score at 2 weeks was 0.5 ± 0.4 [95% CI: -4.582/5.582] and 1.7 ± 1.9 [95% CI: -9.736/13.14] in the group and in the group respectively (p < 0.05). Mean BOP value at baseline was 57.1 ± 15.2% [95% CI: -136.0/250.2] in the group (A) and 55.3% ± 11.7% [95% CI: -93.36/204.0] (p > 0.05) while mean BOP value at 2 weeks follow-up was 14.3% ± 6.6% [95% CI: -69.56/98.16] (A) and 45.4% ± 9.8% [95% CI: -79.12/169.9] (B) respectively (p < 0.05).

Conclusions: A significant reduction in gingival inflammation indexes was found at 2 weeks in patients with peri-implant mucositis treated with a gel with CHX + A.D.S. 0.5% with the addition of PVP-VA and sodium DNA compared to those treated with a placebo gel.

Clinical trial registration: 2019-004976-20.

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含有0.5% A.D.S.、PVP-VA和DNA钠的氯胺定凝胶与安慰剂凝胶治疗种植体周围粘膜炎:一项随机对照试验。
背景:种植体周围粘膜炎是种植体周围软组织的细菌性炎症性疾病。氯己定(CHX)与PVP-VA(聚乙烯吡咯烷酮/醋酸乙烯酯)相结合,在抗菌活性中具有辅助作用:它保护聚合物形成的成膜层免受微生物污染或过度感染,并延长其持久性,而不直接作用于组织和伤口。DNA钠能够改善牙龈营养。该研究的目的是比较含有CHX和抗变色系统(A.D.S.) 0.5%、添加PVP-VA和DNA钠的凝胶与不含氯苄啶的安慰剂凝胶在种植体周围粘膜炎治疗中的作用。方法:试验设计:采用单中心随机对照临床试验,选取24例黏膜炎患者,随机分为两组。在A组(n = 12)中,患者使用CHX + A.D.S. 0.5%凝胶治疗,而在B组(n = 12)中使用安慰剂凝胶治疗。结果:在基线和治疗期后2周评估斑块指数(PI)(主要结果)、探诊出血(BOP)和牙龈指数(GI)(次要结果)。结果:A组和B组基线时PI平均评分分别为2.4±0.4 [95% CI: -2.682/7.482]和2.2±0.5 [95% CI: -4.153/8.553] (p > 0.05), 2周时两组PI平均评分分别为0.5±0.4 [95% CI: -4.582/5.582]和1.7±1.9 [95% CI: -9.736/13.14] (p < 0.05)。A组基线时平均BOP值为57.1±15.2% [95% CI: -136.0/250.2], A组为55.3%±11.7% [95% CI: -93.36/204.0] (p > 0.05),随访2周时平均BOP值分别为14.3%±6.6% [95% CI: -69.56/98.16] (A)和45.4%±9.8% [95% CI: -79.12/169.9] (B) (p < 0.05)。结论:与使用安慰剂凝胶治疗的患者相比,使用CHX + A.D.S. 0.5%添加PVP-VA和DNA钠的凝胶治疗的种植体周围粘膜炎患者在2周时牙龈炎症指标显着降低。临床试验注册:2019-004976-20。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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