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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05304689
Other study ID # RyazSMU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date December 2023

Study information

Verified date March 2023
Source Ryazan State Medical University
Contact Olga Guiter, PhD
Phone +79106159998
Email gos.stam@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation Kseniya Ryazan Ryazan Region

Sponsors (1)

Lead Sponsor Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary quantitative analysis of cytokines PG/ml sampling of oral fluid in the study group of patients 1 year
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