NCT06510608

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

July 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 5, 2024

Last Update Submit

July 14, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mitofusin-1 concentration

    Mitofusin-1 concentration in saliva, determined as a result of biochemical analysis

    Up to four weeks from start of work

  • Mitofusin-2 concentration

    Mitofusin-2 concentration in saliva, determined as a result of biochemical analysis

    Up to four weeks from start of work

  • IL-1B concentration

    IL-1B concentration in saliva, determined as a result of biochemical analysis

    Up to four weeks from start of work

Study Arms (3)

Healthy

Diagnostic Test: Biochemical analysis of saliva sample

Gingivitis

Diagnostic Test: Biochemical analysis of saliva sample

Periodontitis

Diagnostic Test: Biochemical analysis of saliva sample

Interventions

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.

GingivitisHealthyPeriodontitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Okumus OF, Kurt N, Kantarci A. Salivary mitofusin levels in periodontal disease: a cross-sectional case-control study. BMC Oral Health. 2025 Oct 6;25(1):1542. doi: 10.1186/s12903-025-06932-0.

Biospecimen

Retention: SAMPLES WITH DNA

human saliva samples

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesGingivitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 19, 2024

Study Start

July 25, 2024

Primary Completion

August 25, 2024

Study Completion

September 25, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07