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临床试验/NCT04178668
NCT04178668终止不适用

Molecular and Organizational Changes in the Human Oral Mucosa During Aging

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
2
主要终点
Dielectric marker of the oral mucosa : temperature of mode 1 in the hydrated state

研究概览

简要总结

The objective of this interventional with mucosa et saliva samples, monocentric, transversal and pilot study is to extract vibrational, thermal and dielectric markers obtained by Differential Scanning Calorimetry, Thermo-Stimulated Currents and Fourier Transform Infrared spectroscopy on oral mucosa and saliva samples collected from 66 patients divided in two groups (20-40 and 70-90 years old).

详细描述

Edentulism is prevalent in elderly people and the current care is the use of removable denture based on edentulous jaw regions. Nevertheless, the close and extended contact of denture base with mucosa and the transmission of chewing movement trough the complete denture leads to a weakening of supporting tissues in the medium to long term. This embrittlement may be accompanied by pain, compromising the proper integration of complete denture. In geriatrics, the peculiar weakness of bearing surfaces, connected to physio-pathological conditions as well as the decrease of adaptability and resistance further complicate the biomechanical integration of this kind of prosthesis. It has been shown that chronical ageing induces a decrease of resiliency and hydration of oral mucosa, associated with a decrease of epithelium thickness; nevertheless few studies have been performed at the molecular and supramolecular level to characterize this mucosa. Techniques of material characterization (Fourier transform Infrared spectroscopy, Differential scanning calorimetry (DSC), Thermostimulated currents (TSC), have shown their ability to follow hydric, molecular and structural modification of dermis upon ageing. In accordance with this study, the distribution of thermal, vibrational and dielectric markers of oral mucosa will be extracted in two age groups. The principal hypothesis of the research is the possibility to identify specific markers and to follow molecular and organizational changes induced by ageing (intrinsic ageing or extrinsic ageing due to prostheses wearing). The characterization of saliva by Fourier transform infrared spectroscopy (FTIR) shows promise in quantifying the biochemical components of this biofluid. Some vibrational saliva biomarkers have high diagnostic potential (physiological stress, diabetes, salivary lithiasis, carcinomas, periodontitis).This study is a first step to redefine the specification for the most appropriate biomaterial in removable prostheses.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient requiring a classic dental surgery (extraction, implantology...) at the Toulouse University Hospital,
  • Between the ages of 20 and 40 or between 70 and 90 years

排除标准

  • Patient with gastrotomy probes or chemotherapy, palliative care (or with a life expectancy of less than 30 days),
  • Patient with surgical contraindication: allergy to local anesthetics, major hemorrhagic risk: patient on unbalanced Anti Vitamin K, patient on new anticoagulants not relayed or not discontinued,
  • Patient at high risk of infectious endocarditis
  • Patient under safeguard of justice.

结局指标

主要结局

Dielectric marker of the oral mucosa : temperature of mode 1 in the hydrated state

时间窗: Day 0

temperature of mode 1 in the hydrated state

Thermal marker of the oral mucosa: percentage of water related

时间窗: Day 0

percentage of water related

Vibrational marker of the oral mucosa: collagen 1 fraction indicator

时间窗: Day 0

collagen 1 fraction indicator measured by Fourier-transform infrared spectroscopy. It corresponds to the ratio of the band area 1338 cm-1/1750-1000 cm-1

Vibrational marker of the oral mucosa : collagen 2 fraction indicator

时间窗: Day 0

collagen 2 fraction indicator measured by Fourier-transform infrared spectroscopy. It corresponds to the ratio of the band area 1202 cm-1/1750-1000 cm-1

Thermal marker of the oral mucosa : percentage of open water

时间窗: Day 0

percentage of open water

Thermal marker of the oral mucosa : maximum denaturation temperature

时间窗: Day 0

maximum denaturation temperature

Thermal marker of the oral mucosa : percentage of total water

时间窗: Day 0

percentage of total water

Thermal marker of the oral mucosa : collagen denaturation enthalpy

时间窗: Day 0

collagen denaturation enthalpy (in J/g) determined by differential calorimetric analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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