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Completed

NCT Number: NCT07835477

TBC1D15 / Rab7 / Fis1 Pathway 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.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inonu University, Faculty of Dentistry, Deparment of Periodontology, Malatya 44100

Malatya, 44100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Inclusion criteria

for the Healthy Control group:

  • 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.

Inclusion criteria

for the Gingivitis group:

  • presence of ≥ 20 teeth in the mouth
  • PPD ≤ 3 mm,

-% 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.

Inclusion criteria

for the Stage 3 Periodontitis group:

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

TBC1D15-Rab7-Fis1 Dysregulated in Periodontal Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

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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