NCT07758374

Brief Summary

Gum disease, including gingivitis and its more advanced form, periodontitis, is a common condition that damages the tissues supporting the teeth. This study examines how gum disease affects the expression of specific genes and proteins that regulate communication between internal cell structures and the clearance of damaged material. Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already undergoing. These samples will be used to measure the expression levels of the GFI1, NF-κB, and NLRP3 genes/proteins, along with IL-1beta levels. In a separate laboratory experiment, gum cells will be exposed to a substance produced by bacteria commonly associated with gum disease, to observe how these same genes and protein respond. The goal of this study is to better understand the biological changes that occur in gum tissue as gum disease progresses, 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 Jan 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

January 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

periodontitisgingivitisinflammationinflammasome

Outcome Measures

Primary Outcomes (1)

  • GFI1, NLRP3, NF-KB, IL-1beta 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 GFI1, NLRP3, NF-KB, IL-1beta were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis

    January to July 2024

Study Arms (3)

periodontally healthy

periodontally healthy participants

gingivitis

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 (4)

  • Zhu L, Meng Q, Liang S, Ma Y, Li R, Li G, Zeng H. The transcription factor GFI1 negatively regulates NLRP3 inflammasome activation in macrophages. FEBS Lett. 2014 Nov 28;588(23):4513-9. doi: 10.1016/j.febslet.2014.10.025.

    PMID: 25447538BACKGROUND
  • Hock H, Orkin SH. Zinc-finger transcription factor Gfi-1: versatile regulator of lymphocytes, neutrophils and hematopoietic stem cells. Curr Opin Hematol. 2006 Jan;13(1):1-6. doi: 10.1097/01.moh.0000190111.85284.8f.

    PMID: 16319680BACKGROUND
  • Aral K, Berdeli E, Cooper PR, Milward MR, Kapila Y, Karadede Unal B, Aral CA, Berdeli A. Differential expression of inflammasome regulatory transcripts in periodontal disease. J Periodontol. 2020 May;91(5):606-616. doi: 10.1002/JPER.19-0222. Epub 2019 Oct 17.

    PMID: 31557327BACKGROUND
  • Aral K, Milward MR, Kapila Y, Berdeli A, Cooper PR. Inflammasomes and their regulation in periodontal disease: A review. J Periodontal Res. 2020 Aug;55(4):473-487. doi: 10.1111/jre.12733. Epub 2020 Jan 20.

    PMID: 31960443BACKGROUND

MeSH Terms

Conditions

PeriodontitisGingivitisInflammation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

August 6, 2026

First Posted

August 11, 2026

Study Start

January 1, 2024

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

August 11, 2026

Record last verified: 2026-08

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