Clinical and Microbiological Approach in Orthopedic Treatment of Patients When Choosing a Structural Material

NCT05943197 | Recruiting DMC

• 1 other identifier: 10/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Microbiota

Keywords

microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after placing a crown in the mouth

Study Arms (4)

20 patients with zirconia

EXPERIMENTAL

patients who will receive crowns from zirconia

Diagnostic Test: dental prosthetics, biofilm response and oral microbiota

20 e-max patients

EXPERIMENTAL

patients who will receive crowns from e-max

Diagnostic Test: dental prosthetics, biofilm response and oral microbiota

20 patients Cobalt-chromium alloy

EXPERIMENTAL

patients who will receive crowns from Cobalt-chromium alloy

Diagnostic Test: dental prosthetics, biofilm response and oral microbiota

20 patients metal-ceramics

EXPERIMENTAL

patients who will receive crowns from metal-ceramics

Diagnostic Test: dental prosthetics, biofilm response and oral microbiota

Interventions

dental prosthetics, biofilm response and oral microbiota DIAGNOSTIC_TEST

microbiota, biofilm, oral mucosa

20 e-max patients; 20 patients Cobalt-chromium alloy; 20 patients metal-ceramics; 20 patients with zirconia

Eligibility Criteria

• Age: 1 Month - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- need for prosthetics

You may not qualify if:

• \- lack of indications for treatment

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (1)

Gbuz So Sspn3

Samara, Russia

RECRUITING

MeSH Terms

Interventions

Microbiota

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Central Study Contacts

Alexander Nesterov

CONTACT

+79276962515; Nesterov003@rambler.ru

Vladislav Karyashov

CONTACT

+79879593988; stomkvv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: July 13, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)