Oral MicrobiotaNCT05943197
Clinical and Microbiological Approach in Orthopedic Treatment of Patients When Choosing a Structural Material
A study testing dental prosthetics, biofilm response and oral microbiota in people with Oral Microbiota, run by Samara State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 1 to 1 month
- Conditions the study is for
- Oral Microbiota
- What is being tested?
- dental prosthetics, biofilm response and oral microbiota
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- need for prosthetics
Who cannot join
- lack of indications for treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- Conduct an analysis of the need for fixed orthopedic structures among the population at the regional level
- Assess the influence of the material chosen for prosthetics on the species diversity of oral microorganisms
- To study the dependence of the degree of microbial adhesion on the nature of the material and manufacturing technology on various fixed orthopedic structures
- Develop and implement a method for preventing complications in patients with prosthetics using various structural materials
- 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
- 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
- For the first time, an analysis of the results of treatment and the development of complications will be carried out using the proposed method.
- 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
- 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
- Conditions
- Oral Microbiota
- Being tested
- dental prosthetics, biofilm response and oral microbiota
- Keywords
- microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental prosthetics, biofilm response and oral microbiotaDiagnostic test
microbiota, biofilm, oral mucosa
| Study group | Role | What they receive |
|---|---|---|
| 20 patients with zirconia | Experimental | patients who will receive crowns from zirconia Receives: Diagnostic Test: dental prosthetics, biofilm response and oral microbiota |
| 20 e-max patients | Experimental | patients who will receive crowns from e-max Receives: Diagnostic Test: dental prosthetics, biofilm response and oral microbiota |
| 20 patients Cobalt-chromium alloy | Experimental | patients who will receive crowns from Cobalt-chromium alloy Receives: Diagnostic Test: dental prosthetics, biofilm response and oral microbiota |
| 20 patients metal-ceramics | Experimental | patients who will receive crowns from metal-ceramics Receives: Diagnostic Test: dental prosthetics, biofilm response and oral microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiological research
Before the installation of an orthopedic structure in the oral cavity, microbiological material is taken from the periodontal cavity of the tooth on which the orthopedic structure will be installed. Next, an orthopedic structure is installed for a period of 1 month, after which the structure is removed from the oral cavity, for re-analysis and comparison of changes in the microbiota of the oral cavity, depending on the selected structural material There will be measurements of the size of the tissues of the oral cavity, depending on the choice of material for prosthetics, using molecular genetic, biochemical, microbiological studies.
Measured: 1 month after placing a crown in the mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943197
- Sponsor's protocol ID
- 10/2022
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Approach in Orthopedic Treatment of Patients When Choosing a Structural Material
- ClinicalTrials.gov ID
- NCT05943197
- Acronym / sponsor ID
- 10/2022
- Conditions
- Oral Microbiota
- Keywords
- microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Conduct an analysis of the need for fixed orthopedic structures among the population at the regional level
- Assess the influence of the material chosen for prosthetics on the species diversity of oral microorganisms
- To study the dependence of the degree of microbial adhesion on the nature of the material and manufacturing technology on various fixed orthopedic structures
- Develop and implement a method for preventing complications in patients with prosthetics using various structural materials
- 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
- 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
- For the first time, an analysis of the results of treatment and the development of complications will be carried out using the proposed method.
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 patients with zirconia | Experimental | Diagnostic Test: dental prosthetics, biofilm response and oral microbiotapatients who will receive crowns from zirconia |
| 20 e-max patients | Experimental | Diagnostic Test: dental prosthetics, biofilm response and oral microbiotapatients who will receive crowns from e-max |
| 20 patients Cobalt-chromium alloy | Experimental | Diagnostic Test: dental prosthetics, biofilm response and oral microbiotapatients who will receive crowns from Cobalt-chromium alloy |
| 20 patients metal-ceramics | Experimental | Diagnostic Test: dental prosthetics, biofilm response and oral microbiotapatients who will receive crowns from metal-ceramics |
Who may qualify
- Ages
- 1 to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- need for prosthetics
Key exclusion criteria (1 listed)
- lack of indications for treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental prosthetics, biofilm response and oral microbiotamicrobiota, biofilm, oral mucosa | Diagnostic test | 20 e-max patients, 20 patients Cobalt-chromium alloy, 20 patients metal-ceramics, 20 patients with zirconia |
Primary outcome
microbiological research
Time frame: 1 month after placing a crown in the mouth
Before the installation of an orthopedic structure in the oral cavity, microbiological material is taken from the periodontal cavity of the tooth on which the orthopedic structure will be installed. Next, an orthopedic structure is installed for a period of 1 month, after which the structure is removed from the oral cavity, for re-analysis and comparison of changes in the microbiota of the oral cavity, depending on the selected structural material There will be measurements of the size of the tissues of the oral cavity, depending on the choice of material for prosthetics, using molecular genetic, biochemical, microbiological studies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental prosthetics, biofilm response and oral microbiota in people with Oral Microbiota, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiological research (time frame: 1 month after placing a crown in the mouth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.