NCT07705048

Brief Summary

Gum disease, including gingivitis and more advanced periodontitis, is a common condition that damages the tissues supporting the teeth. This study looks at how gum disease affects specific proteins inside gum tissue cells that help control how cells communicate between their internal structures and clean out damaged material (a process called autophagy). Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already having. These samples will be tested to measure the levels of three proteins (called PTPIP51, VAPB, and LC3B) and calcium. In a separate laboratory experiment, gum cells will be exposed to a substance made by bacteria commonly linked to gum disease, to see how these same proteins respond. The goal of this study is to better understand the biological changes that happen in gum tissue as gum disease develops, which may help guide future research into new treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 10, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

periodontitisgingivitismitochondriaendoplasmic reticulum

Outcome Measures

Primary Outcomes (1)

  • Gingival PTPIP51, VAPB, and LC3B Gene and Protein Expression

    Gene expression (RT-PCR, relative fold change via 2\^-ΔΔCT method) and protein expression (Western blot, band intensity normalized to ACTB) of PTPIP51, VAPB, and LC3B were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis

    From February to July 2024

Study Arms (3)

periodontally healthy

periodontally healthy participants

gingivitis group

patients with gingivitis

periodontitis

patients with periodontitis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 to 60 years attending the periodontology clinic were enrolled and classified into three groups based on clinical periodontal parameters according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III). Exclusion criteria included any systemic disease, regular medication use, smoking, 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 60 participants (20 per group; 30 male, 30 female) were included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (3)

  • Kirmizigul OA, Sabanci A, Disli F, Yildiz S, Milward MR, Aral K. Evaluation of the role of mitofusin-1 and mitofusin-2 in periodontal disease. J Periodontol. 2024 Jan;95(1):64-73. doi: 10.1002/JPER.23-0072. Epub 2023 Jul 24.

    PMID: 37436713BACKGROUND
  • Aral K, Milward MR, Cooper PR. Gene expression profiles of mitochondria-endoplasmic reticulum tethering in human gingival fibroblasts in response to periodontal pathogens. Arch Oral Biol. 2021 Aug;128:105173. doi: 10.1016/j.archoralbio.2021.105173. Epub 2021 May 27.

    PMID: 34058723BACKGROUND
  • Gomez-Suaga P, Paillusson S, Stoica R, Noble W, Hanger DP, Miller CCJ. The ER-Mitochondria Tethering Complex VAPB-PTPIP51 Regulates Autophagy. Curr Biol. 2017 Feb 6;27(3):371-385. doi: 10.1016/j.cub.2016.12.038. Epub 2017 Jan 26.

    PMID: 28132811BACKGROUND

MeSH Terms

Conditions

PeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 15, 2026

Study Start

February 1, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

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