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

Sponsor

Ryazan State Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05304689

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammation	Diagnostic Test: test for quantitative index of interleukins in the oral fluid	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

two groups of patientstwo groups of patients

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: test system for the determination of interleukins 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

Arm

Intervention/Treatment

Other: test system for the determination of interleukins

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

Outcome Measures

Primary Outcome Measures

quantitative analysis of cytokines PG/ml [1 year]
sampling of oral fluid in the study group of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kseniya	Ryazan	Ryazan Region	Russian Federation	390026

Sponsors and Collaborators

Ryazan State Medical University

Investigators

Study Director: Olga Guiter, PhD, research leader

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ryazan State Medical University

ClinicalTrials.gov Identifier:

NCT05304689

Other Study ID Numbers:

RyazSMU

First Posted:

Mar 31, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ryazan State Medical University

Denture, Removable, Cytokine, Saliva, Jaw

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Aug 4, 2022