Genotoxicity Assessment of Dental Implants in Gingival Epithelial Cells
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cytotoxic and/or genotoxic
研究概览
简要总结
Due to the strong correlation between genotoxicity and carcinogenesis, it is necessary to clarify the potential genotoxic effects of titanium dental implant systems. As most dental materials release small amounts of several elements into the oral cavity, proper regulations have to guarantee that the concern from genotoxicity/mutagenicity of dental materials is annulated or at the lowest possible level. Thus, further biocompatibility records are needed in order to evaluate the comprehensive risks of these compounds. In a view of the above-mentioned data, the aim of this in vivo study is to evaluate genotoxic and cytotoxic potential of implants and gingiva formers from two different implant systems in gingival epithelial cells.
Exfoliated gingival cells will be taken from 80 participants before and after 90 days of dental implant insertion, and 21 days following gingiva former placement. DNA damage will be analyzed using the micronucleus test. Tested dental implants will be Ankylos and Dentium, with corresponding gingival former.
详细描述
Patients are divided into two groups depending on the dental implant system used in the therapy. Ankylos dental implants (Dentsplay Sirona, Charlotte, USA) are used in the first group of patients and Dentium SuperLine (Dentium Co., Seoul, Korea) in the second group.
The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
The surgeries are performed under local anesthesia and systemic antibiotics were given according to standard procedure. To ensure post-surgical oral hygiene, patients are advised to rinse the oral cavity with chlorhexidine until the day of sutures' removal. The sutures are removed10 day after implantation. The implants are healing by being submerged for 12 weeks based on the surgeon's clinical judgment, indications given and the need and preference of the patients. After healing, gingiva formers are placed.
Sample collection and a micronucleus assay in gingival epithelial cells To reduce individual variations, patients are observed longitudinally and each subject is served as their own control. Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).
One hour before the sampling, the participants abstain from consuming any food and drinks. After rinsing of the oral cavity 3 times with tepid water to remove exfoliated cells, a T0 swab is taken by gently brushing the gingiva around place indicated for implant placement and later T1 and T2 around implant with a cytobrush (Cytobrush Plus; GmbH. Dietramszell-Linden, Germany). The samples are subsequently applied to coded laboratory glass slides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •absence of a single tooth in the mandibular molar or premolar region
- •belonging to ASA I or ASA II group
- •absence of titanium hypersensitivity
- •absence of prosthetic restoration/replacement or orthodontic appliances in the oral cavity, -absence of oral precancerous lesions
- •no history of radiation in the head and neck area
- •absence of bisphosphonates and corticosteroids used in therapy.
排除标准
- •presence of systemic disease (e.g. uncontrolled diabetes, oral mucosal diseases, untreated gingivitis and periodontitis, endodontic lesions)
- •pocket depths ≥ 4 mm on adjacent teeth
- •poor oral hygiene
- •pregnant and lactating women
- •taking of antibiotics in the last three months
- •taking any other pharmaceutics that have been proved to elevate DNA damage,
- •underwent medical radiation diagnostics
- •using mouthwash that contain alcohol
- •history of radiation in the head and neck area.
结局指标
主要结局
Cytotoxic and/or genotoxic
时间窗: 1 year
Evaluation of the cytotoxic and genotoxic alterations in gingival epithelial cells after application of titanium-based dental implant system
次要结局
未报告次要终点
研究者
Daniel Jerković
DMD
University of Zagreb