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

About this trial
This is an interventional diagnostic trial for Chronic Inflammation focused on measuring Denture, Removable, Cytokine, Saliva, Jaw
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.
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
NCT ID
NCT05304689
First Posted
January 31, 2022
Last Updated
July 23, 2023
Sponsor
Ryazan State Medical University
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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