PeriodontitisNCT06510608
Periodontal Disease and Salivary Mitofusin Levels
An observational study of Periodontitis and Periodontal Diseases, run by Erzincan University.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Gingivitis
- What is being tested?
- Biochemical analysis of saliva sample
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2024to 25 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with gingivitis and periodontitis presenting to the periodontology clinic, as well as healthy individuals
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Periodontitis, Periodontal Diseases, Gingivitis
- Being tested
- Biochemical analysis of saliva sample
- Medical subject headings
- Periodontitis, Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical analysis of saliva sampleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described Receives: Diagnostic Test: Biochemical analysis of saliva sample | |
| Gingivitis | Not described Receives: Diagnostic Test: Biochemical analysis of saliva sample | |
| Periodontitis | Not described Receives: Diagnostic Test: Biochemical analysis of saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitofusin-1 concentration
Mitofusin-1 concentration in saliva, determined as a result of biochemical analysis
Measured: Up to four weeks from start of work
Mitofusin-2 concentration
Mitofusin-2 concentration in saliva, determined as a result of biochemical analysis
Measured: Up to four weeks from start of work
IL-1B concentration
IL-1B concentration in saliva, determined as a result of biochemical analysis
Measured: Up to four weeks from start of work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start25 Jul 2024 (estimated)
- Primary completion25 Aug 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Okumuş, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510608
- Sponsor's protocol ID
- EUDF-OKUMUS-004
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41053720
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Roles of Salivary Mitofusin-1 and Mitofusin-2 Levels in Periodontal Disease
- ClinicalTrials.gov ID
- NCT06510608
- Acronym / sponsor ID
- EUDF-OKUMUS-004
- Conditions
- Periodontitis, Periodontal Diseases, Gingivitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 25 Aug 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Biochemical analysis of saliva sample |
| Gingivitis | – | Diagnostic Test: Biochemical analysis of saliva sample |
| Periodontitis | – | Diagnostic Test: Biochemical analysis of saliva sample |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gingivitis and periodontitis presenting to the periodontology clinic, as well as healthy individuals
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemical analysis of saliva sampleIt 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. | Diagnostic test | Gingivitis, Healthy, Periodontitis |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 41053720Okumus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Periodontal Diseases, run by Erzincan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitofusin-1 concentration (time frame: Up to four weeks from start of work). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.