含0.5% A.D.S.、聚乙烯吡咯烷酮-醋酸乙烯酯和脱氧核糖核酸钠的洗必泰凝胶与安慰剂凝胶治疗种植体周围黏膜炎：一项随机对照试验性临床试验

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.

作者信息

Lorusso Felice, Tartaglia Gianluca, Inchingolo Francesco, Scarano Antonio

机构信息

Department of Innovative Technologies in Medicine and Dentistry, University of Chieti-Pescara, 66100 Chieti, Italy.

Department of Biomedical, Surgical and Dental Sciences, School of Dentistry, University of Milan, 20122 Milan, Italy.

出版信息

Front Biosci (Elite Ed). 2022 Oct 31;14(4):30. doi: 10.31083/j.fbe1404030.

DOI:10.31083/j.fbe1404030

PMID:36575845

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) ( > 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 ( < 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] ( > 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 ( < 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.

摘要

背景

种植体周围黏膜炎是一种种植体周围软组织的细菌性炎症性疾病。洗必泰（CHX）与聚乙烯吡咯烷酮/醋酸乙烯酯（PVP-VA）联合使用具有辅助抗菌活性：由于聚合物的作用，它可保护成膜层免受微生物污染或过度感染，并延长其持久性，而对组织和伤口无直接作用。脱氧核糖核酸钠能够改善牙龈营养。本研究的目的是比较一种含CHX和0.5%防变色系统（A.D.S.）并添加了PVP-VA和脱氧核糖核酸钠的凝胶与一种不含洗必泰的安慰剂凝胶在种植体周围黏膜炎治疗中的效果。

方法

试验设计：对总共24例黏膜炎患者进行了一项单中心随机对照试验性临床试验，随机分为两组。A组（n = 12）患者用含CHX + 0.5%A.D.S.的凝胶治疗，而B组（n = 12）使用安慰剂凝胶。

结果

在基线时，A组的平均菌斑指数（PI）评分为2.4±0.4[95%可信区间：-2.682/7.482]，B组为2.2±0.5[95%可信区间：-4.153/8.553]（>0.05）；而在2周时，A组的平均PI评分为0.5±0.4[95%可信区间：-4.582/5.582]，B组为1.7±1.9[95%可信区间：-9.736/13.14]（<0.05）。基线时A组的平均探诊出血（BOP）值为57.1±15.2%[95%可信区间：-136.0/250.2]，B组为55.3%±11.7%[95%可信区间：-93.36/204.0]（>0.05）；而在2周随访时，A组的平均BOP值为14.3%±6.6%[95%可信区间：-69.56/98.16]，B组为45.4%±9.8%[95%可信区间：-79.12/169.9]（<0.05）。