NCT05304689

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 25, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

January 31, 2022

Last Update Submit

July 23, 2023

Conditions

Chronic Inflammation

Keywords

Denture, Removable, Cytokine, Saliva, Jaw

Outcome Measures

Primary Outcomes (1)

  • quantitative analysis of cytokines PG/ml

    sampling of oral fluid in the study group of patients

    1 year

Study Arms (1)

test system for the determination of interleukins

OTHER

test system for the determination of interleukins

Diagnostic Test: test for quantitative index of interleukins in the oral fluid

Interventions

test for quantitative index of interleukins in the oral fluidDIAGNOSTIC_TEST

collection of oral fluid and determination of the content of cytokines by test systems in patients with postoperative wound

test system for the determination of interleukins

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kseniya

Ryazan, Ryazan Oblast, 390026, Russia

RECRUITING

Study Officials

  • Olga Guiter, PhD

    research leader

    STUDY DIRECTOR

Central Study Contacts

Olga Guiter, PhD

CONTACT

+79106159998gos.stam@mail.ru

Kseniya Inzhuvatova

CONTACT

+79156154757medvedeva.xeniya2011@yandex.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: two groups of patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 31, 2022

Study Start

November 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

July 25, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)