TBC1D15 / Rab7 / Fis1 Pathway in Periodontal Disease

NCT07835477 | Completed

• 1 other identifier: 2026/9130
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Gingivitis; Periodontitis

Keywords

periodontitis; gingivitis; mitochondria; Fis1; Rab7

Outcome Measures

Primary Outcomes (5)

• Mean RAB7 protein level in gingival crevicular fluid

  RAB7 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.

  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.

  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.

  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.

  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.

  At the time of GCF sampling

Study Arms (3)

periodontally healthy

periodontally healthy participants

gingivitis

patients with gingivitis

periodontitis

patients with periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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%,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

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

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 38749178 BACKGROUND

• Yang 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.

  PMID: 38583680 BACKGROUND

• Luo 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.

  PMID: 39734056 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Periodontitis; Charcot-Marie-Tooth disease, Type 2B

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 23, 2026
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 24 months following article publication
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by the corresponding author, for the purpose of achieving the aims outlined in the approved proposal.

Locations

TU (1)