Analysis of the Relationship Between the Quantitative Index of Cytokines in the Oral Fluid and Inflammation

July 23, 2023 updated by: Ryazan State Medical University

Analysis of the Interconnection Between the Quantitative Indicators Cytokines in the Oral Fluid and the Local Inflammatory Process at the Stage of Orthopedic Rehabilitation of Patients With Postoperative Jaw Defects.

The of study is to increase the effectiveness of orthopedic rehabilitation of patients with postoperative jaw defects using various types of replacement structures, taking into account the clinical and morphofunctional characteristics of oral tissues after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Formation of three groups of patients Patients with extensive jaw defects after surgery for oncological disease of the middle zone of the face (10 people) Patients with jaw defects after complicated tooth extraction (20 people) Healthy volunteers to determine reference values (5 people) Data on the functional state of the dentoalveolar system in the study groups of patients will be obtained.

An assessment will be made of the rate of formation of a postoperative defect in patients with postoperative jaw defects, depending on the design features of the prosthesis.

Defects of the jaw will be replaced with orthopedic structures, taking into account the individual characteristics of the state of the marginal part of the defect.

Data will be obtained on the rate of adaptation and quality of life in patients using dentures made taking into account the assessment of the state of the marginal part of the defect.

Clinical recommendations for dentists will be proposed, which will optimize the process of orthopedic dental treatment, taking into account the state of the marginal part of the defect in patients with postoperative jaw defects.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men or women over 30 years of age. The presence of a postoperative defect of the jaw after surgical interventions.

Exclusion Criteria:

  • Men or women under 30 years of age. Decompensated somatic pathology. Pregnancy or breastfeeding in women. Participation in another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: test system for the determination of interleukins
Diagnostic test: test for quantitative index of interleukins in the oral fluid
collection of oral fluid and determination of the content of cytokines by test systems in patients with postoperative wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative analysis of cytokines PG/ml
Time Frame: 1 year
sampling of oral fluid in the study group of patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryazan State Medical University

Investigators

  • Study Director: Olga Guiter, PhD, research leader

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RyazSMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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