Use of Supramolecular Solvents in the Identification and Quantification of Substances of Very High Concern and Endocrine Disruptors Released From Michigan-type Occlusal Splints in Saliva: in Vitro and in Vivo Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Identification of endocrine disruptors (EDs) or substances of concern of very high concern (SVHC)in saliva released by Michigan type occlusal splints before, during and after their application.
研究概览
简要总结
The effects of endocrine disruptors (EDs) are well known. Therefore, the aim of this observational study is to analyse saliva samples from volunteers who request a bruxism splint, before, during and after fitting, to find out whether they are assimilated by the body, answering the following questions:
- Do Michigan-type splints release endocrine disruptors or substances of particular concern?
- In what concentration are they present in saliva?
Participants will be asked to take saliva samples at different times over a period of 6 months. This will also be accompanied by the relevant clinical and oral history. A previous in vitro study is required, which is complemented by an in vivo study. The methodology is new in dentistry: super solvents which, combined with liquid chromatography coupled to a mass spectrometer (LC-HRMS), allows a wider range of substances to be detected, in a more ecological and simpler way, as they are not organic solvents derived from petroleum. The splint is chosen because it is an everyday treatment, which is increasingly in demand, especially after the pandemic. It is subdivided into two types, depending on the method of manufacture: injected and printed (more ecofriendly).
详细描述
DESCRIPTION:
This is a prospective analytical observational analytical experimental pilot study with the aim of analysing substances of particular concern and endocrine disruptors detected in saliva, released by conventional dental devices, before and after the intervention. They will therefore be paired samples, where the control group will be the same subject, minimising the independent variables: saliva pH, microbiome, salivary flow, habits, occlusal wear, erosion by external agents and saliva.
Saliva sampling will be carried out according to the conventional protocol RD 1716/2011. The saliva containers will comply with the requirements of ISO 6717:2021. They shall be packaged and transported according to the protocol Order JUS/1291/2010 of 13 May. All samples shall be identified with the number assigned to the volunteer, time, material and type of manufacture (processed, machined or printed), and shall be sent to the Chemical Institute for Energy and Environment (IQUEMA). University of Cordoba, where they will be analysed by the SAC group, for subsequent statistical treatment and interpretation.
POPULATION AND SAMPLE CALCULATION. The sample will be obtained from patients who are registered in the database of the Polyclinic of the European University of Madrid, who request a Michigan type splint for the treatment of bruxism, made of acrylic, made in two of the usual ways: printed or injected, in accordance with the inclusion and exclusion criteria shown in Appendix I. As the samples are treated with an innovative methodology in the field of dentistry, such as super solvents, this is a pilot study in which two groups of 15 participants each are formed, depending on the manufacturing process of the splint: injected or printed, totalling 30 volunteers.
STUDY PERIOD Recruitment is expected to be completed in January 2024, and sample collection is expected to be completed in September 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be of legal age
- •Be able to attend Polyclinic for 6 months.
- •Require an acrylic relaxation splint type Michigan
- •Not be pregnant
- •Not be breastfeeding
排除标准
- •Be a minor
- •Allergy to any type of plastic material, acrylic or resins for dental use.
结局指标
主要结局
Identification of endocrine disruptors (EDs) or substances of concern of very high concern (SVHC)in saliva released by Michigan type occlusal splints before, during and after their application.
时间窗: 6 months
Treatment of samples by addition of hexanol and tetrahydrofuran. The solutions will be analysed by liquid chromatography coupled to a LC-HRMS mass spectrometer.
Quantification of endocrine disruptors or substances of very high concern (SVHC) in saliva released from Michigan type occlusal splints before, during and after application.
时间窗: 6 months
LC-HRMS (Liquid chromatography-high resolution mass spectrometry). Maximum dose recommended by the FDA (Food and Drug Administration): 4 micrograms/kilo/day in adults.
次要结局
- Quantification of endocrine disruptors (EDs) or substances of very high concern (SVHCs) released from Michigan-type occlusal splints simulating oral environment and wear and tear(1 month)
- Identification of endocrine disruptors or substances of very high concern (SVHC) released from Michigan-type occlusal splints in vitro simulating oral environment and wear.(1 month)
研究者
Susana David Fernández
PhD
Universidad Europea de Madrid