Periodontal Disease and Salivary Mitofusin Levels

July 14, 2024 updated by: Ömer Faruk Okumuş, Erzincan University

Evaluation of the Roles of Salivary Mitofusin-1 and Mitofusin-2 Levels in Periodontal Disease

The aim of this observational study is to find out whether there is a level difference in salivary mitofusin-1 and mitofusin-2 levels due to changes in periodontal status. The main question it aims to answer is:

  • Do salivary mitofusin-1 and mitofusin-2 levels of periodontitis patients differ from healthy patients?
  • Could salivary mitofusin-1 and mitofusin-2 levels be biomarkers for periodontal disease?

Biochemical analysis will be performed on saliva samples taken at once from gingivitis or periodontitis patients and healthy individuals who apply to the periodontology clinic, at the initial stage of the treatment. There is no ongoing monitoring or second sampling.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

81

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with gingivitis and periodontitis presenting to the periodontology clinic, as well as healthy individuals

Description

Inclusion Criteria:

  • Being between the ages of 18 and 65.
  • Willing to participate in the study and provide a saliva sample.
  • Having a healthy periodontal condition, gingivitis, or periodontitis (Stage 3-4, Grade C).
  • Having fasted from any food or drink (except water) for the past 2 hours prior to providing the saliva sample.
  • Having refrained from brushing teeth or using mouthwash in the past 2 hours prior to providing the saliva sample.
  • Not having any systemic diseases.
  • Not currently taking any medications regularly.

Exclusion Criteria:

  • Having used antibiotics within the last 6 months.
  • Having received periodontal treatment within the last 6 months.
  • Having fewer than 20 teeth (excluding third molars).
  • Having any systemic diseases.
  • Not smoking or having quit at least 5 years ago.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
Diagnostic test: Biochemical analysis of saliva sample
It is the examination of saliva samples taken with biochemical methods. In this way, the substances in its content and the concentration of cytokines are analyzed.
Periodontitis
Diagnostic test: Biochemical analysis of saliva sample
It is the examination of saliva samples taken with biochemical methods. In this way, the substances in its content and the concentration of cytokines are analyzed.
Gingivitis
Diagnostic test: Biochemical analysis of saliva sample
It is the examination of saliva samples taken with biochemical methods. In this way, the substances in its content and the concentration of cytokines are analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitofusin-1 concentration
Time Frame: Up to four weeks from start of work
Mitofusin-1 concentration in saliva, determined as a result of biochemical analysis
Up to four weeks from start of work
Mitofusin-2 concentration
Time Frame: Up to four weeks from start of work
Mitofusin-2 concentration in saliva, determined as a result of biochemical analysis
Up to four weeks from start of work
IL-1B concentration
Time Frame: Up to four weeks from start of work
IL-1B concentration in saliva, determined as a result of biochemical analysis
Up to four weeks from start of work

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2024

Primary Completion (Estimated)

August 25, 2024

Study Completion (Estimated)

September 25, 2024

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDF-OKUMUS-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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