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NCT Number: NCT06510608

Periodontal Disease and Salivary Mitofusin Levels

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biochemical analysis of saliva sample

Diagnostic Test

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Erzincan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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