GingivitisNCT07835477
TBC1D15 / Rab7 / Fis1 Pathway in Periodontal Disease
An observational study of Gingivitis and Periodontitis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study will look at certain proteins in the fluid found around the gums (called gingival crevicular fluid, or GCF) of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Dec 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: Adults aged 18 to 65 years attending the periodontology clinic were enrolled and classified into 3 groups based on clinical periodontal parameters and smoking status according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III Grade B). Exclusion criteria included any systemic disease, regular medication use, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 72 participants (24 per group; 36 males, 36 females) were included.
Who may be able to join
- presence of ≥ 20 teeth in the mouth-probing pocket depth (PPD) ≤ 3 mm
- the percentage of bleeding sites for the whole mouth < 10%, on radiographic examination
- a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
- presence of ≥ 20 teeth in the mouth
- PPD ≤ 3 mm,
- -% of bleeding sites for the whole mouth ≥ 10%,
Show all 14Show fewer
- on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
- presence of ≥ 15 teeth in the mouth
- more than 30% of teeth affected by periodontal disease
- affected teeth exhibiting probing depths of 6 mm or more
- clinical attachment loss (CAL) of ≥ 5 mm,
- vertical bone loss of 3 mm or more
- class 2 or 3 furcation involvement
- radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth
Who cannot join
- presence of any systemic disease
- regular use of any medication
- pregnancy or lactation
- periodontal treatment within the last 6 months
- antibiotic use within the last 6 months
- the presence of prosthetic restorations on the teeth to be sampled
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry, Deparment of Periodontology, Malatya 44100
Malatya, 44100
About this study
Official title: TBC1D15-Rab7-Fis1 Dysregulated in Periodontal Disease
This study will look at certain proteins in the fluid found around the gums (called gingival crevicular fluid, or GCF) of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease).
The proteins being studied, TBC1D15, Rab7, and Fis1, help control the health of mitochondria, which act like tiny "power plants" inside our cells. When mitochondria become damaged, the body normally breaks them down and recycles them through a process these proteins help control. It is not yet known how this process relates to gum disease.
Read more
Seventy-two healthy adults will take part in this study and will be grouped based on the health of their gums. A sample of gum fluid (GCF) will be collected from each participant and tested to measure the levels of these proteins.
Researchers want to find out whether the levels of these proteins change as gum disease becomes more severe. If levels differ between people with healthy gums and those with periodontitis, this may suggest that problems with mitochondrial health and cleanup play a role in how gum disease develops and gets worse.
This information may help researchers better understand the biological processes involved in gum disease and could eventually lead to new ways to detect or treat it earlier.
Read the detailed description
This study will examine the levels of certain proteins in the gingival crevicular fluid (GCF) of individuals with healthy gingiva, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins to be studied, TBC1D15, Rab7, and Fis1, are known to play roles in mitochondrial fission and mitophagy, processes closely linked to cellular energy metabolism and cell health, but their role in periodontal disease is not well understood.
Seventy-two healthy adults will be grouped according to their periodontal health status, and GCF samples will be collected and analyzed from each participant. Researchers will measure the levels of these proteins and look for patterns linking them to the severity of gum disease.
The results are expected to show whether TBC1D15, Rab7, and Fis1 levels differ in individuals with periodontitis compared to those with healthy gingiva, suggesting that these proteins may contribute to the development and progression of periodontal disease through mitochondrial dysfunction and dysregulated mitophagy. This information may help researchers better understand the biological processes underlying periodontal disease and could eventually contribute to new approaches for its detection or treatment.
- Conditions
- Gingivitis, Periodontitis
- Keywords
- periodontitis, gingivitis, mitochondria, Fis1, Rab7
- Medical subject headings
- Gingivitis, Periodontitis, Charcot-Marie-Tooth disease, Type 2B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontally healthy | periodontally healthy participants | |
| gingivitis | patients with gingivitis | |
| periodontitis | patients with periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean RAB7 protein level in gingival crevicular fluid
RAB7 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Measured: At the time of GCF sampling
Mean Fis1 protein level in gingival crevicular fluid
Fis1 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Measured: At the time of GCF sampling
Mean TBC1D15 protein level in gingival crevicular fluid
TBC1D15 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Measured: At the time of GCF sampling
Mean NLRP3 protein level in gingival crevicular fluid
NLRP3 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Measured: At the time of GCF sampling
Mean IL-1β protein level in gingival crevicular fluid
IL-1β protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Measured: At the time of GCF sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 May 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Aral, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835477
- Sponsor's protocol ID
- 2026/9130
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared, including participant age, sex, and clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing). Participants will be identified only by coded/numbered case report forms; no names, gender identity beyond biological sex, or other identifying information will be shared.
Publications
Dou X, Qiao L, Song X, Chang J, Zeng X, Zhu L, Deng T, Yang G, Xu C. Biogenic selenium nanoparticles alleviate intestinal barrier injury in mice through TBC1D15/Fis1/Rab7 pathway. Biomed Pharmacother. 2024 Jun;175:116740. doi: 10.1016/j.biopha.2024.116740. Epub 2024 May 14.
PubMed 38749178Yang Y, Lin Q, Zhu X, Shao X, Li S, Li J, Wu J, Jin H, Qi C, Jiang N, Zhang K, Wang Q, Gu L, Ni Z. Activation of lipophagy is required for RAB7 to regulate ferroptosis in sepsis-induced acute kidney injury. Free Radic Biol Med. 2024 Jun;218:120-131. doi: 10.1016/j.freeradbiomed.2024.04.213. Epub 2024 Apr 5.
PubMed 38583680Luo L, Wu Q, Xiao Q, Chen Y, Deng Z, Cen C, Lin J. Lipotoxicity-induced upregulation of FIS1 exacerbates mitochondrial fragmentation and promotes NLRP3-dependent pyroptosis in diabetic cardiomyopathy. Free Radic Biol Med. 2025 Feb 16;228:183-196. doi: 10.1016/j.freeradbiomed.2024.12.049. Epub 2024 Dec 27.
PubMed 39734056
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBC1D15-Rab7-Fis1 Dysregulated in Periodontal Disease
- ClinicalTrials.gov ID
- NCT07835477
- Acronym / sponsor ID
- 2026/9130
- Conditions
- Gingivitis, Periodontitis
- Keywords
- periodontitis, gingivitis, mitochondria, Fis1, Rab7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Sep 2026 (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.
This study will look at certain proteins in the fluid found around the gums (called gingival crevicular fluid, or GCF) of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease).
The proteins being studied, TBC1D15, Rab7, and Fis1, help control the health of mitochondria, which act like tiny "power plants" inside our cells. When mitochondria become damaged, the body normally breaks them down and recycles them through a process these proteins help control. It is not yet known how this process relates to gum disease.
Seventy-two healthy adults will take part in this study and will be grouped based on the health of their gums. A sample of gum fluid (GCF) will be collected from each participant and tested to measure the levels of these proteins.
Researchers want to find out whether the levels of these proteins change as gum disease becomes more severe. If levels differ between people with healthy gums and those with periodontitis, this may suggest that problems with mitochondrial health and cleanup play a role in how gum disease develops and gets worse.
This information may help researchers better understand the biological processes involved in gum disease and could eventually lead to new ways to detect or treat it earlier.
Detailed description
This study will examine the levels of certain proteins in the gingival crevicular fluid (GCF) of individuals with healthy gingiva, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins to be studied, TBC1D15, Rab7, and Fis1, are known to play roles in mitochondrial fission and mitophagy, processes closely linked to cellular energy metabolism and cell health, but their role in periodontal disease is not well understood.
Seventy-two healthy adults will be grouped according to their periodontal health status, and GCF samples will be collected and analyzed from each participant. Researchers will measure the levels of these proteins and look for patterns linking them to the severity of gum disease.
The results are expected to show whether TBC1D15, Rab7, and Fis1 levels differ in individuals with periodontitis compared to those with healthy gingiva, suggesting that these proteins may contribute to the development and progression of periodontal disease through mitochondrial dysfunction and dysregulated mitophagy. This information may help researchers better understand the biological processes underlying periodontal disease and could eventually contribute to new approaches for its detection or treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontally healthy | – | –periodontally healthy participants |
| gingivitis | – | –patients with gingivitis |
| periodontitis | – | –patients with periodontitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 65 years attending the periodontology clinic were enrolled and classified into 3 groups based on clinical periodontal parameters and smoking status according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III Grade B). Exclusion criteria included any systemic disease, regular medication use, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 72 participants (24 per group; 36 males, 36 females) were included.
Key inclusion criteria (14 listed)
- presence of ≥ 20 teeth in the mouth-probing pocket depth (PPD) ≤ 3 mm
- the percentage of bleeding sites for the whole mouth < 10%, on radiographic examination
- a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
- presence of ≥ 20 teeth in the mouth
- PPD ≤ 3 mm,
Key exclusion criteria (6 listed)
- presence of any systemic disease
- regular use of any medication
- pregnancy or lactation
- periodontal treatment within the last 6 months
- antibiotic use within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean RAB7 protein level in gingival crevicular fluid
Time frame: At the time of GCF sampling
RAB7 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Mean Fis1 protein level in gingival crevicular fluid
Time frame: At the time of GCF sampling
Fis1 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Mean TBC1D15 protein level in gingival crevicular fluid
Time frame: At the time of GCF sampling
TBC1D15 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Mean NLRP3 protein level in gingival crevicular fluid
Time frame: At the time of GCF sampling
NLRP3 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Mean IL-1β protein level in gingival crevicular fluid
Time frame: At the time of GCF sampling
IL-1β protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 38749178Dou X, Qiao L, Song X, Chang J, Zeng X, Zhu L, Deng T, Yang G, Xu C. Biogenic selenium nanoparticles alleviate intestinal barrier injury in mice through TBC1D15/Fis1/Rab7 pathway. Biomed Pharmacother. 2024 Jun;175:116740. doi: 10.1016/j.biopha.2024.116740. Epub 2024 May 14.
- Background: PubMed 38583680Yang Y, Lin Q, Zhu X, Shao X, Li S, Li J, Wu J, Jin H, Qi C, Jiang N, Zhang K, Wang Q, Gu L, Ni Z. Activation of lipophagy is required for RAB7 to regulate ferroptosis in sepsis-induced acute kidney injury. Free Radic Biol Med. 2024 Jun;218:120-131. doi: 10.1016/j.freeradbiomed.2024.04.213. Epub 2024 Apr 5.
- Background: PubMed 39734056Luo L, Wu Q, Xiao Q, Chen Y, Deng Z, Cen C, Lin J. Lipotoxicity-induced upregulation of FIS1 exacerbates mitochondrial fragmentation and promotes NLRP3-dependent pyroptosis in diabetic cardiomyopathy. Free Radic Biol Med. 2025 Feb 16;228:183-196. doi: 10.1016/j.freeradbiomed.2024.12.049. Epub 2024 Dec 27.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared, including participant age, sex, and clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing). Participants will be identified only by coded/numbered case report forms; no names, gender identity beyond biological sex, or other identifying information will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontitis, run by Inonu University at 1 site in Turkey (Türkiye).
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 14 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean RAB7 protein level in gingival crevicular fluid (time frame: At the time of GCF sampling). The study lists 5 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 NCT07835477, which also lists 3 linked publications.
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 23 Sep 2026.