复方苯佐卡因凝胶的局部毒性研究

目的评价复方苯佐卡因凝胶的局部刺激性和致敏性。方法依照国家食品药品监督管理局《化学药物刺激性、过敏性和溶血性研究技术指导原则》(以下简称指导原则),采用大鼠口腔黏膜刺激性实验法、兔眼刺激性实验法以及豚鼠皮肤致敏实验法。结果复方苯佐卡因凝胶给大鼠口腔正常黏膜连续涂药3次,相当于3 g.kg-1,均无刺激和毒性反应;一次性按每只0.1 g给兔眼结膜涂药,亦未出现刺激性反应;给每只豚鼠皮肤0.2 g致敏接触和激发接触,均无过敏反应发生。结论复方苯佐卡因凝胶对口腔黏膜无刺激性,对皮肤也没有致敏性。     

复方硼酸含漱液局部用药的毒性研究

目的探讨复方硼酸含漱液局部用药的毒性作用。方法选用SD大鼠和白色豚鼠,分别进行复方硼酸含漱液的局部口腔黏膜刺激试验和过敏试验。口腔黏膜刺激试验分为复方硼酸含漱液组和生理盐水对照组,观察记录给药后24h～7dSD大鼠的全身状况及口腔黏膜反应情况。过敏试验除复方硼酸含濑液组外,另设空白对照组（生理盐水组）和阳性对照组（2,4-二硝基氯苯组）,激发接触试验6、24、48、72h观察皮肤过敏反应及全身反应情况。结果SD大鼠口腔给予复方硼酸含漱液,未发现口腔黏膜组织异常,证明复方硼酸含漱剂对口腔黏膜无刺激性;豚鼠过敏实验结果显示复方硼酸含漱液皮肤用药,未出现过敏反应。结论复方硼酸含漱液局部用药毒性试验显示其无口腔黏膜刺激性和致敏性,提示复方硼酸含漱液作为口腔外用含漱液临床用药安全。     

球囊式中空赝复体用硅橡胶的生物安全性研究

目的 初步评价球囊式中空赝复体用硅橡胶（SRISP）的生物安全性,为后期临床应用提供依据。方法 参照国家标准GB/T 16886.10-2005、YY/T 0127.13-2009和GB/T 16886.11-2011规定的方法,采用最大剂量致敏试验、口腔黏膜刺激试验以及短期全身毒性试验（经口途径）评价SRISP的体内生物安全性。结果 最大剂量致敏试验：豚鼠腹部移去敷贴24、48、72 h后,无红斑、水肿,致敏率为0,SRISP无潜在致敏性;口腔黏膜刺激试验：金黄地鼠缝合部位黏膜未见出血、肿胀,组织学观察未出现病理性改变,SRISP无口腔黏膜刺激性;短期全身毒性试验：大鼠未见临床毒性体征,体重稳定增长,灌胃前后实验组和对照组大鼠体重与体重相对增长率差异无统计学意义（P>0.05）,SRISP无短期全身毒性。结论 经动物实验表明SRISP具有良好的体内生物安全性,有望用于制作赝复体以修复颌骨缺损。     

复方苯佐卡因凝胶对试验性牙痛模型的影响

目的 对比仿制药复方苯佐卡因凝胶与其被仿制品Orajel Mouth-Aid (OMA)的镇痛作用.方法 采用电刺激家兔牙髓法和光电刺激大鼠尾巴法.结果 局部给药后,复方苯佐卡因凝胶和OMA均能提高动物痛阈,有良好的镇痛作用且具有剂量依赖性.结论 复方苯佐卡因凝胶和OMA均有镇痛作用且作用强度相当,可用于牙痛的治疗.     

新型口腔修复用钛锆铌锡合金的生物安全性评价

目的:评价高强度、高弹性模量的新型口腔修复用钛锆铌锡合金的生物安全性。方法:参照国标GB/T16886.5-2003,GB/T16886.10-2005,YY-T0279-1995,YY-T0127.2-1993所规定的方法,分别进行细胞毒性试验、豚鼠最大剂量迟发型致敏试验、口腔黏膜刺激试验以及急性全身毒性试验。结果:细胞毒性试验显示本研究制备的钛锆铌锡合金细胞相对增殖度为124%,细胞毒性反应分级为0级,无细胞毒性;致敏试验表明移去斑贴物24、48h后,试验动物贴敷部位均无红斑和水肿出现,反应积分为0。根据皮肤致敏实验分级标准,Ti-Zr-Nb-Sn合金对豚鼠无明显的潜在致敏性;口腔黏膜刺激试验未见异常组织学反应;短期全身毒性试验显示无明显短期全身毒性。结论:可以初步认为Ti-Zr-Nb-Sn合金是一种合金具有良好生物安全性口腔修复用金属材料。     

高原护唇膏多次皮肤给药的刺激性及过敏性研究

目的:观察高原护唇膏多次接触家兔的完整皮肤和破损皮肤是否产生刺激性及过敏性.方法:家兔共8 只,分为2 组,设完整皮肤和破损皮肤2 个模型组;家兔背部左右两侧分别设高原护唇膏组和阴性组,护唇膏多次1 g/只接触完整皮肤或破损皮肤,观察有无明显的局部刺激反应.豚鼠18 只,随机分为3 组,分别设高原护唇膏组、阴性组和阳性药物组,观察其过敏情况.结果:高原护唇膏对家兔完整皮肤和破损皮肤均无刺激性;豚鼠皮肤正常,无任何过敏反应发生.结论:高原护唇膏在规定剂量下可安全使用.     

纯中药口腔含漱液对皮肤黏膜的刺激性及杀菌作用

目的 观察纯中药口腔含漱液对皮肤、黏膜的刺激反应及对口腔常见细菌的杀菌效果。方法 分别用自制纯中药含漱液和生理盐水对14只5个月龄家兔滴左、右眼7 d;并涂抹10只7个月龄豚鼠左、右侧臀部、腹部、背部（涂药前脱毛）,左右对照,分别于涂抹后第3、7天各处死5只,制作病理切片。分别将金黄色葡萄球菌、大肠埃希氏菌、白念菌、铜绿假单胞菌、乙型链球菌制取的菌悬液加入含不同浓度纯中药含漱液或复方硼砂含漱液（朵贝尔 液）的营养液中,观察细菌的生长情况。分别将黏性放线菌、消化链球菌、核梭杆菌制取的菌液加入等2倍稀释的复方硼砂溶液和纯中药含漱液中,观察有无细菌生长。采用 SPSS17.0软件包对数据进行统计学分析。结果 家兔右眼结膜与对照组相比,无明显充血、发红等变化;豚鼠右侧臀部、腹部、背部皮肤与对照组相比,无明显红肿、皮炎等变化。纯中药含漱液对上述需氧菌和厌氧菌的杀菌效果均显著高于对照组。结论 纯中药含漱液对皮肤、黏膜无刺激反应,对口腔常见细菌有杀菌效果。     

柔性陶瓷材料的体内安全性评价

目的:探索柔性陶瓷材料作为口腔接触类材料的生物安全性能,为临床应用提供理论支持.方法:实验参照GB/T16886医疗器械生物学评价系列标准,制备材料浸提液或纽扣样试件进行皮肤刺激实验、皮内反应实验、迟发型超敏反应实验、口腔黏膜刺激实验及急性全身毒性实验.结果:柔性陶瓷材料无刺激性、不引起皮内反应、无致敏性、无口腔黏膜刺...     

复方苯佐卡因凝胶治疗豚鼠口腔溃疡的实验研究

目的:对比仿制药复方苯佐卡因凝胶(以下简称凝胶)与其被仿品(美国非处方药品"Orajel Mouth-Aid,OMA)"对实验性口腔溃疡治疗作用。方法:采用醋酸、细菌或真菌诱发豚鼠口腔溃疡模型观察药物抗口腔溃疡作用。结果:局部给药,凝胶和OMA均能显著促进醋酸、细菌或真菌诱发的豚鼠口腔溃疡愈合,均具有剂量依赖性。结论:凝胶和OMA均具有促进口腔溃疡愈合作用,两药作用强度相当。     

两种彩色正畸托槽的口腔黏膜刺激试验

目的 评价应用表面化学着色工艺和磁控溅射法两种方法制备的彩色不锈钢正畸托槽的口腔黏膜刺激性,为新材料在口腔临床中的安全应用提供依据.方法 60～70 d鼠龄的雄性金黄色地鼠20只,随机分为2组,将两种彩色正畸托槽分别缝合固定于两组动物的右侧颊囊,将阴性对照材料缝合固定于每组动物的左侧颊囊,14 d后无痛处死动物,取与材料接触部位的颊部全层组织,苏木素-伊红(HE)染色,评价两种材料的口腔黏膜组织刺激反应.结果 20只动物均未出现全身及口腔黏膜局部的不良刺激反应.结论 两种彩色正畸托槽均无口腔黏膜刺激性.     

Adverse effect of dentine bonding agent on the oral mucosa of guinea pigs

The purpose of present study was to determine the possibility of nebulous discoloration of the oral mucosa of guinea pigs as a result of the application of dentine bonding agents. The materials used were the Clearfil Photo Bond (CPB) system's mixture agent, universal agent and catalyst agent. Four types of experimental catalysts were used. In male albino guinea pigs weighing 300-500 g, oral mucosa irritation tests were performed in accordance with the guidelines of the Cosmetic, Toiletry and Fragrance Association (CTFA). Macroscopical findings on the oral mucosa showed that there was strong nebulous discoloration immediately after application of CPB mix and CPB catalyst and throughout the experimental periods. However, CPB without 10-methacryloxdecyl dihydrogen phosphate (MDP) did not produce noticeable nebulous discoloration and inflammation. The CPB mix caused pathological changes, such as paraketosis and hyperkeratosis on the endepidermis of the mucosa, immediately after its application.     

立体光固化成型氧化锆陶瓷的生物安全性评价

目的 评价立体光固化成型氧化锆陶瓷的生物安全性.方法 依照国标GB/T 16886.5—2017、GB/T 16886.10—2017及医药行业标准YY/T 0127.14—2009、YY/T 0127.13—2018对该陶瓷材料进行实验,包括体外细胞毒性实验、皮肤致敏实验、急性经口毒实验及黏膜刺激实验.结果 体外细胞...     

Biological evaluation of a polyvinyl siloxane impression material.

OBJECTIVES: The aim of this study was to determine the irritant properties of a new polyvinyl siloxane impression material (Ghenesil, Lascod-Italy) after single application to intact skin of the rabbit. METHODS: The material was evaluated for primary skin irritation according to the UNI EN ISO 10993-10:1996 using three healthy male New Zealand White rabbits. The back of the animals was clipped free of fur and divided into four sites with the same area 24 h before application of the sample. The material was applied to only two sites; the other two were used as controls. All the sites were covered by gauze and the back of the rabbit was wrapped with a non-occlusive bandage. After 4 h, the bandage and the test material were removed; 1h later the sites were examined for skin irritation and the observation was repeated after 24, 48 and 72 h. The Score of Primary Irritation (SPI) was calculated for each animal and the Primary Irritation Index (PII) was calculated as the arithmetical mean of SPI values. RESULTS: The PII of the test material resulted 0.06. SIGNIFICANCE: Based on present results, it can be concluded that the primary skin irritation of the polyvinyl siloxane impression material tested can be considered negligible.     

Splenocyte cytokine profile in mouse with oral mucosa-sensitization and oral-tolerization by NiSO(4)

Metals used in the oral cavity have been reported to cause various allergic diseases of the skin and mucosa. Skin manifestations due to dental restorations appear not only in the oral cavity, but also on the hands, feet or the whole body, as in the cases of pustulosis palmoplantaris and lichen planus. These phenomena implicate different pathogeneses from that of conventional skin sensitization and tolerance. Therefore, we compared skin and oral mucosa sensitization with nickel and oral tolerance for nickel in a mouse model. Female C57BL/6J mice were sensitized by injection of NiSO(4) into the skin or oral mucosa. Allergic reactions were evaluated by the mouse ear swelling test and splenocyte proliferation and cytokine profiles. Skin and oral mucosa sensitization succeeded in all mice. Ear swelling was significantly greater in the skin- than in the oral mucosa-sensitized mice at 48 hr after challenge. Ear swelling was also suppressed by single oral administration of NiSO(4) in both the skin- and oral mucosa-sensitized mice to the level of that in nonsensitized mice. Splenocytes from skin-sensitized mice proliferated similarly to those from oral mucosa-sensitized mice. Splenocytes from orally-tolerized mice also showed similar proliferation activity to those from skin and oral mucosa-sensitized mice. In the challenge phase, IL-2, IFN-γ, and IL-10 production was induced in splenocytes from both skin- and oral mucosa-sensitized mice. However, IL-4 was induced only in those from skin-sensitized mice. In addition, IL-4 in splenocytes from oral mucosa-sensitized mice was up-regulated to the level in those from skin-sensitized mice by oral tolerance. These results suggest that sensitization sites in mice influence not only the degree of excitation, but also Th-1 and Th-2 balance in the challenge phase and oral tolerance.     

Treatment of a traumatic ulcer on a handicapped individual: a case report

Ulcerations of oral mucosa caused by trauma or irritation are not uncommon. Irritation of tissues by fractured teeth or rough restorations often results in ulcerations. Additionally, oral habits have been reported to produce untoward tissue response.¹ Fortunately, most traumatic oral ulcerations respond rapidly and favorably to removal of the source of irritation. In the case of handicapped individuals, removal of the causative factor may be difficult because of the inability to communicate and cooperate. This is particularly true when the oral lesion is caused by habitual behavior. Some habits may have serious sequela. Phelan and others² reported on a deaf-mute child who had the habit of thumbsucking. Blood loss from an ulceration precipitated by this habit resulted in hospitali-zation and fluid replacement.
The case reported in this paper identifies an unusual problem found in a 9-year-old child with excessive lip sucking that perpetuated a large lip ulceration.     

牙体修复性纳米羟基磷灰石复合材料生物相容性评价

目的:初步评价牙体修复性纳米羟基磷灰石复合材料的生物相容性,为其临床应用的安全性提供实验室依据。方法:采用ISO评价标准中的部分体内试验方法,通过不同途径进行动物急性毒性实验、热原实验、过敏实验、口腔黏膜刺激实验、皮肤刺激实验,根据相关标准评价该材料的生物相容性。结果:该新型材料对生物机体无致热性、无致敏性、无刺激性,无明显急性毒性。结论:牙体修复性纳米羟基磷灰石复合材料对机体组织无明显毒害作用,具有良好的生物相容性。     

Contact sensitivity reactions in the oral mucosa

Although the role of T cells in skin contact sensitivity (CS) immune reactions has been intensely studied, much less is known about the regulatory properties of T cells in the oral mucosa. Animal experiments have shown that hapten sensitization of the ectodermal oral mucosa leads to antigen-specific hypersensitivity reactions in the skin. Furthermore, oral mucosa or skin hapten sensitization resulted in CS inflammatory reactions in the oral mucosa on challenge. The oral mucosa CS responses were similar to those found skin with regard to cell phenotypes and cytokines. CS-like reactions were also found in the oral mucosa after exposure to an irritant detergent, sodium lauryl sulfate (SLS). The oral mucosa reacted at smaller SLS doses than did skin. Ions and molecules released fron dental restorative materials (together with saliva and food and/or beverages) expose the gastrointestinal mucosa continuously over long time periods. From animal experiments we have learned that mice given antigen by gastric feeding, subsequently antigen-sensitized on skin, and finally elicited in the oral mucosa and in ear skin, showed tolerance in skin but gave simultaneous CS inflammatory reactions in the oral mucosa. Moreover, exposure of colon mucosa to antigen produced CS reactions in oral mucosa after challenge. Are there CS reactions in the oral mucosa? Clinical and experimental studies indicate that the oral mucosa can function both as induction and expression site of CS. The GI tract may be an important modifier of the CS inflammatory reactions seen in the oral mucosa.     

Light microscopic study of experimental cell-mediated immunity in rat oral mucosa

A model for hapten-induced cell-mediated immunity (CMI) in the oral mucosa of the Spraque-Dawley rat is presented. Sensitization was performed with 0.1 ml of a hapten (DNCB 2%, in acetone solution) administered five times on shaved dorsal skin. Ten days after completed sensitization, eliciting doses of 0.1–0.02% of the hapten were applied in the buccal mucosa one or several times giving rise to an inflammation dominated by lymphocytes. The development of the reaction was studied in a time sequence study. Also sensitization through the buccal mucosa was attempted, with three or more of the eliciting doses applied directly in the buccal mucosa. Light microscopically, the reaction was identical to the one seen in previously sensitized rats. The effects of DNCB and DNFB on sensitized animals with eliciting doses of 25 μl 2% or 0.02% in acetone/olive oil were compared. No differences were seen in the low concentration range, but in the high concentration range, DNFB showed a more potent effect giving rise to ulcers, not observed with DNCB.