Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05943197 |
| Other study ID # |
10/2022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
January 2023 |
| Source |
Samara State Medical University |
| Contact |
Alexander Nesterov |
| Phone |
+79276962515 |
| Email |
Nesterov003[@]rambler.ru |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Today, there is a wide range of structural materials on the market, different in chemical,
physical and biological properties, and information about them is very often limited only by
the manufacturer's instructions, which allows to determine, at best, only the scope. In this
regard, there are difficulties in choosing the optimal material for this particular
situation, since without a thorough approach to studying the properties of the main materials
used in dentistry, it seems difficult to provide high-quality dental care, the result of
which is functional usefulness, aesthetics and durability.The problem of an individual
approach to the choice of structural material from the standpoint of personalized medicine is
even less studied - there are no data in the literature on the role of normal and pathogenic
microflora in the development of destructive changes in structures and the development of
complications, taking into account a personalized approach when analyzing the composition of
the microbiota of the oral cavity, biochemical parameters of the oral fluid, blood depending
on the material from which the structure is made.
Description:
Relevance of the topic Today, there is a wide range of structural materials on the market,
different in chemical, physical and biological properties, and information about them is very
often limited only by the manufacturer's instructions, which allows to determine, at best,
only the scope. In this regard, there are difficulties in choosing the optimal material for
this particular situation, since without a thorough approach to studying the properties of
the main materials used in dentistry, it seems difficult to provide high-quality dental care,
the result of which is functional usefulness, aesthetics and durability.The problem of an
individual approach to the choice of structural material from the standpoint of personalized
medicine is even less studied - there are no data in the literature on the role of normal and
pathogenic microflora in the development of destructive changes in structures and the
development of complications, taking into account a personalized approach when analyzing the
composition of the microbiota of the oral cavity, biochemical parameters of the oral fluid,
blood depending on the material from which the structure is made.
Purpose of the study Improving the efficiency of orthopedic treatment of patients with
dentition defects based on a clinical and microbiological personalized approach
Research objectives:
1. Conduct an analysis of the need for fixed orthopedic structures among the population at
the regional level
2. Assess the influence of the material chosen for prosthetics on the species diversity of
oral microorganisms
3. To study the dependence of the degree of microbial adhesion on the nature of the
material and manufacturing technology on various fixed orthopedic structures
4. Develop and implement a method for preventing complications in patients with prosthetics
using various structural materials
5. Conduct a comparative assessment of the orthopedic treatment of patients using the
developed method for the prevention of complications and the traditional method based on
clinical and functional research methods
Material (object) of research:
The clinical part of the study is carried out at the Department of Orthopedic of dentistry of
Samara State Medical University on the basis of GBUZ SO SSP No. 3 g.o. Samara. To solve the
tasks of the study, an analysis of the clinical observation of patients. Planned orthopedic
treatment 20 patients with zirconia 20 e-max patients 20 patients Cobalt-chromium alloy 20
patients Biological material will be taken from each patient before the delivered structure
and after 1 month of the structure's arrival in the oral cavity
Research methods:
Clinical
- hygiene indexes
- CPU index Microbiological
- MALDI-ToF mass spectrometry Clinical diagnostic research
- biochemical study of saliva
- biochemical blood test X-ray examination Scientific novelty of the work
1. For the first time, a personalized approach will be developed in the choice of
structural material for the manufacture of dentures based on a clinical and
microbiological study
2. For the first time, an analysis of the results of treatment and the development of
complications will be carried out using the proposed method.
3. For the first time, a cultural study of the composition of microorganisms of the
oral mucosa will be carried out, depending on the selected material
4. For the first time, a model of microbiological examination of patients will be
scientifically substantiated when choosing a structural material Practical
significance
- For the first time, an algorithm for orthopedic treatment will be proposed
when choosing a structural material depending on the microbiology of the oral
cavity
- For the first time, methods will be proposed for determining the influence of
oral microflora on orthopedic structures, taking into account individual
characteristics
- For the first time, an algorithm for microbiological examination of patients
for prosthetics will be proposed
- For the first time, biomarkers will be proposed to assess the microbial
composition of the oral cavity to justify the choice of design
