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

Primary Purpose

Chronic Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
test for quantitative index of interleukins in the oral fluid
Sponsored by
Ryazan State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Inflammation focused on measuring Denture, Removable, Cytokine, Saliva, Jaw

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • KseniyaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

test system for the determination of interleukins

Arm Description

test system for the determination of interleukins

Outcomes

Primary Outcome Measures

quantitative analysis of cytokines PG/ml
sampling of oral fluid in the study group of patients

Secondary Outcome Measures

Full Information

First Posted
January 31, 2022
Last Updated
July 23, 2023
Sponsor
Ryazan State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05304689
Brief Title
Analysis of the Relationship Between the Quantitative Index of Cytokines in the Oral Fluid and Inflammation
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ryazan State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammation
Keywords
Denture, Removable, Cytokine, Saliva, Jaw

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
two groups of patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
test system for the determination of interleukins
Arm Type
Other
Arm Description
test system for the determination of interleukins
Intervention Type
Diagnostic Test
Intervention Name(s)
test for quantitative index of interleukins in the oral fluid
Intervention Description
collection of oral fluid and determination of the content of cytokines by test systems in patients with postoperative wound
Primary Outcome Measure Information:
Title
quantitative analysis of cytokines PG/ml
Description
sampling of oral fluid in the study group of patients
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Guiter, PhD
Phone
+79106159998
Email
gos.stam@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Kseniya Inzhuvatova
Phone
+79156154757
Email
medvedeva.xeniya2011@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Guiter, PhD
Organizational Affiliation
research leader
Official's Role
Study Director
Facility Information:
Facility Name
Kseniya
City
Ryazan
State/Province
Ryazan Region
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kseniya Inzhuvatova
Phone
+79156154757
Email
medvedeva.xeniya2011@yandex.ru
First Name & Middle Initial & Last Name & Degree
Olga Guyter, Ph.D.
Phone
+79106159998
Email
gos.stam@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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